Zimmer Recalls ITST Anti-Rotation Screws and Femoral Intramedullary Nails
Zimmer is recalling ITST anti-rotation screws and femoral intramedullary nails due to unvalidated packaging operations at its Puerto Rico facility.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The source text notes that seal integrity testing met acceptance criteria, suggesting the risk is theoretical or low, fitting the 'voluntary precautionary recalls' criterion for a Moderate severity score.
Plain-English summary
Zimmer, Inc. is recalling ITST anti-rotation screws and femoral intramedullary nails in various diameters and lengths. The recall affects 7,044,680 units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that packaging operations at this specific facility were not properly validated. Although subsequent seal integrity testing showed that the packaging tray configurations met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in this location as a precaution.
The affected products were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom. Healthcare providers and patients should check their inventory and patient records for these specific catalog numbers and contact Zimmer for further instructions.
The recalled product
- Product
- ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
- Manufacturer
- Zimmer, Inc.
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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