Events

Rappel de Device Recall 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Synthes (USA) Products LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79157
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0904-2018
  • Date de mise en oeuvre de l'événement
    2017-07-26
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161456
  • Notes / Alertes
    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
    Reamer - Product Code HTO
  • Cause
    Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
  • Action
    The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps: ¿ Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you DO have any of the identified devices, and are returning the product for replacement, please take the following steps: ¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. ¿ Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return ¿ Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. ¿ Return the Verification Section (page 4 of this letter) with the product to: o Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea

Device

Device Recall 3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile
  • Modèle / numéro de série
    Distributed 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632 4/3/2017 2026-02-28 H311229 4/16/2017 2026-03-31 H311228 4/28/2017 2026-03-31 H311231 4/28/2017 2026-03-31 H319172 4/28/2017 2026-03-31 H319175 4/28/2017 2026-03-31 H318789 5/4/2017 2026-03-31 H319171 5/4/2017 2026-03-31 H327068 5/4/2017 2026-03-31 H311226 5/6/2017 2026-03-31 H311225 5/11/2017 2026-04-30 H311224 5/12/2017 2026-04-30 H327067 5/12/2017 2026-04-30 H327066 5/18/2017 2026-04-30
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.
  • Description du dispositif
    3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S || Reaming Rods are intended for guiding of reamers during orthopedic surgery.
  • Manufacturer
    Synthes (USA) Products LLC

Manufacturer

Synthes (USA) Products LLC
  • Adresse du fabricant
    Synthes (USA) Products LLC, 1301 Goshen Pkwy, West Chester PA 19380-5986
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA