Zimmer Recalls Bone Screws Due to Unvalidated Packaging Operations
Zimmer is recalling 7,044,680 units of Herbert Bone Screws and Cannulated Bone Screws because packaging operations at a Puerto Rico facility were not properly validated.
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 temporary or medically reversible adverse health consequence. The source text notes that seal integrity testing met acceptance criteria, suggesting the risk is precautionary rather than based on confirmed failures or reported injuries.
Plain-English summary
Zimmer, Inc. is recalling 7,044,680 units of HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE SCREW products. The recall affects units that were sterile packaged in the Building 1 packaging operations at the Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The products were distributed nationwide in the United States and in numerous international countries, including Belgium, Canada, China, Germany, India, Japan, and the United Kingdom.
The recall was initiated after Zimmer reviewed historic packaging validations and determined that the packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing indicated that the packaging tray configurations met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired manufacturing lots from this specific facility to ensure safety.
Healthcare providers and patients should check their inventory and patient records for these specific products. If you have used or possess these items, contact Zimmer, Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
- 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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