Events

Recall of Standard CoCr Heads

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66500
  • Event Risk Class
    Class 2
  • Event Number
    Z-1034-2014
  • Event Initiated Date
    2013-10-11
  • Event Date Posted
    2014-02-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124901
  • Notes / Alerts
    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.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Reason
    Zimmer recently conducted a review of all historic packaging validations at its zimmer manufacturing b.V. (zmbv) facility in ponce, puerto rico. based on this review, it was determined that the packaging operations conducted in the building 1 packaging operation at this facility were not properly validated. as a result, zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. the acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. these packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the zmbv facility building 1 packaging operations.
  • Action
    Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Device

Standard CoCr Heads
  • Model / Serial
    369934 60308845 60508319 60588077 60670902 60701935 60779840 60790101 60810357 60847644 60906703 61077837 61077838 61191243 61191244 61247015 61304729 61340542 61401735 61485227 61530679 61551614 61555020 61670831 61720512 61774878 61790557 61837158 62025229 62124070 62176438 369935 60339031 60407279 60586160 60658085 60701954 60701967 60779852 60779856 60779863 60806208 60821916 60847645 60900931 61002276 61052833 61077839 61077840 61191246 61304732 61401736 61448090 61502826 61530680 61570271 61618471 61618472 61713710 61734540 61837159 61837160 61896789 62025230 62091051 62176441 62284369 60339030 60392901 60440343 60508338 60656885 60669433 60779864 60779866 60779867 60790102 60806209 60821917 60847646 61002277 61052834 61077841 61144531 61191245 61304736 61401737 61485225 61530678 61551616 61551617 61670830 61713709 61734539 61774872 61779845 61790554 61896791 61896792 62025231 62025232 62124069 62176444 62218172 60323824 60439671 60508340 60536879 60611544 60652728 60684197 60779872 60790103 60847647 60906704 61002278 61077842 61191242 61224848 61304741 61340544 61424894 61485226 61618473 61676503 61713708 61774879 61779846 61790560 61896793 62025233 62093451 62176446 62218173 60439652 60515401 60593679 60701996 60884548 60940020 61018982 61077843 61081687 61191241 61224849 61304743 61459434 61535709 61618470 61683763 61720514 61774871 61779847 61837161 61896795 62025234 62098854 62099285
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
  • Product Description
    6 DEGREE COCR FEM HEAD 36
  • Manufacturer
    Zimmer, Inc.

Manufacturer

Zimmer, Inc.
  • Manufacturer Address
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA