U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Probe - Product Code HXB
Cause
During cleaning, two separate units of the nexgen tibial base plates did not fit with the tibial base plate handle.
Action
Zimmer, Inc. sent recall letters/ hospital risk managers emails and letters via courier service on December 2, 2014. Inventory Return Certification Forms were also provided. Your responsibilities are:
1. Locate all products from the identified lot above and quarantine them immediately.
2. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1), and email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com.
3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1) to the specified address.
4. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager letter directly.
5. Please notify Zimmer of any hospitals that you have further distributed the affected product to. Supply the information for any hospitals that you have identified, as well as the affected surgeons using the provided spreadsheet template. Zimmer will notify the additional surgeons and hospitals you identify via Fed Ex mailing. The template will be emailed to you for completion and return to corporatequality.postmarket@zimmer.com.
6. Ensure that a copy of the Risk Managers letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer.
7. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Biomet emailed a new letter with correct distribution dates on 1/16/2015.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Action
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
Notes supplémentaires dans les données
Source: NCAR
Cause
Device failure / feature after commissioning - mechanical failure.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Finland.
Notes supplémentaires dans les données
Source: M2
Cause
Device failure / feature before use - material / component.