—#124858

Product

MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001

FDA product code: KMC — Prosthesis, Hip, Semi-Constrained, Composite/Metal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K936044
Affected lot / code info: 365614 369469 60101996 60101997 60156488 60156489 60178356 60187896 60202868 60202869 60257213 60261647 60266457 60273995 60273996 60324337 60411690 60411691 60428980 60457742 60474620 60474621 60474622 60646263 60646264 60646265 60708475 60797297 60822088 60867060 60899017 60899018 60945798 61104294 61199990 61222220 61282924 61293845 61320383 61336983 61336985 61522992 61550876 61555656 61664260 365612 369617 370353 370412 60065984 60113194 60135098 60135109 60156491 60179688 60242116 60242117 60273997 60294371 60345749 60457743 60600426 60646268 60708476 60803408 60846356 60899019 60945799 60979573 61172283 61199988 61282925 61320379 61339628 61460816 61550877 61664258 60242118 60324338 60428996 60474623 61222221

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-10-11
Posted by FDA: 2014-02-20
Terminated: 2017-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.