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
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
Cause
Pedicle screw may disengage in post op period requiring intervention.
Action
Blackstone Medical notified Distributors by email on 12/23/05 to quarantine inventory. A letter notifying physicans was issued 12/28/05 via Fed''X. Product is to be returned to Blackstone Medical.
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.
Voids in the porous coating of a component used in total hip replacement surgery.
Action
Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians.
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
Screwdriver - Product Code HXX
Cause
Depth indicators are incorrectly labeled (etched) on a measurement instrument.
Action
The firm notified its direct consignees of the problem with the product and requested the return of any inventory via letter dated 12/22/05.
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
Plate, Fixation, Bone - Product Code HRS
Cause
Screwdriver pilot taper tip can break during surgery.
Action
Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.
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.
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.
Misbranded-the package actually contains an apr hip system, ha porous stem, 12 mm, left.
Action
Firm''s sales representatives were notified via email on 2/22/06 to visit the customers, remove the product from inventory, and to return it to the firm.
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.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
Action
Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.
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.
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
Action
Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.
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.
Due to a manufacturing error, after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving, the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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.
Due to a manufacturing error after autoclaving the tubular retractor coating, physical vapor deposition (pvd) black titanium nitride (tin), may rub off.
Action
The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.
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
Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
Cause
The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
Action
Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
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
Fastener, Fixation, Biodegradable, Soft Tissue - Product Code MAI
Cause
The inserter shafts bend, as they were manufactured with a different stainless steel than specified.
Action
Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.
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
Screw, Fixation, Bone - Product Code HWC
Cause
There may be an obstruction in the cannula that will prevent the guide wire from passing through it. the obstruction in the cannula can force the guidewire to advance further into the patient than intended.
Action
Pioneer notified Zimmer via letter dated 3/3/06 and Zimmer notified their hospital customers and distribution sites via letters dated 3/10/06 to check their inventory and return the product immediately to Zimmer.
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.
A c-clip located near the rasp connection end of the instrument may detach during use and fall into the patient.
Action
Firm sales personnel were notified by letter dated 2/8/06 to visit each of their affected accounts and to remove the c-clip from the rasps or to remove the instrument from the hospital and return it to the firm. Similar instructions issued by letter dated 2/27/06 when the recall was extended to the two additional products.