Zimmer Recalls NEXGEN Osteotomy Cortical Bone Screws Due to Packaging Validation
Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
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: This is a voluntary precautionary recall initiated after a validation review, where the product actually passed the subsequent seal integrity testing, fitting the criteria for a low-risk or precautionary action.
Plain-English summary
Zimmer, Inc. is recalling NEXGEN Osteotomy Cortical Bone Screws (item codes starting with 0052500) due to a review of historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The review determined that packaging operations in Building 1 were not properly validated.
Although Zimmer conducted seal integrity testing and the packaging tray configurations met the acceptance criteria for sterile barrier integrity, the company decided to recall all non-expired manufacturing lots that were sterile packaged in the affected facility operations. The recall covers 7,044,680 units distributed nationwide in the United States and in numerous international countries.
Consumers and healthcare providers should check their inventory for the specific item codes listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or Zimmer, Inc. according to the company's instructions.
The recalled product
- Product
- NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
- 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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