MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1018-2014
Related Recalls
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.