2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT
Class I - DangerousWhat Should You Do?
- Check if you have this product: 61173335 61173337 61173339 61173340 61173341 61115956 61173344 61173346 61173347 61173349 61173350 61173352 61173353 61173354 61173355 61173356 61173357 61173358 61173359 61173360 61173361 61173362 61173363 61173364 61173365 61173366 61359816
- 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:
2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12 CORT SCREW/SELFT 2.7 X 14 CORT SCREW/SELFT 2.7 X 16 CORT SCREW/SELFT 2.7 X 18 CORT SCREW/SELFT 2.7 X 20 CORT SCREW/SELFT 2.7 X 22 CORT SCREW/SELFT 2.7 X 24 CORT SCREW/SELFT 2.7 X 26 CORT SCREW/SELFT 2.7 X 28 CORT SCREW/SELFT 2.7 X 30 CORT SCREW/SELFT 2.7 X 32 CORT SCREW/SELFT 2.7 X 34 CORT SCREW/SELFT 2.7 X 36 CORT SCREW/SELFT 2.7 X 38 CORT SCREW/SELFT 2.7 X 40 CORT SCREW/SELFT 2.7 X 42 CORT SCREW/SELFT 2.7 X 44 CORT SCREW/SELFT 2.7 X 45 CORT SCREW/SELFT 2.7 X 46 CORT SCREW/SELFT 2.7 X 48 CORT SCREW/SELFT 2.7 X 50 CORT SCREW/SELFT 4.0 X 20 CANC SCREW/SELFT
Product Codes/Lot Numbers:
61173335 61173337 61173339 61173340 61173341 61115956 61173344 61173346 61173347 61173349 61173350 61173352 61173353 61173354 61173355 61173356 61173357 61173358 61173359 61173360 61173361 61173362 61173363 61173364 61173365 61173366 61359816
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1041-2014
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.