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6 Degree Cocr Fem Head 36 recallZ-1034-2014 · Zimmer, Inc. · initiated Oct 11, 2013

Class II Terminated All recalls posted in February 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-1034-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 11, 2013
Posted by the FDA
Feb 20, 2014
Recalling firm
Zimmer, Inc.
Quantity
7,044,680 total
Product code
LPH
FDA submissions
K953337
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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

22 devices cleared under K953337 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 66500).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page