Zimmer Recalls Versa-FX II Knee Implants Due to Packaging Validation Issues
Zimmer is recalling Versa-FX II knee implants 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 due to a lack of proper packaging validation, despite the products passing subsequent seal integrity testing. No illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling specific lots of Versa-FX II knee implants, including the Keyless Tube, Keyless Short, Short Tube PL, Std Tube Plat, and Supracondylar models. The affected products are identified by item codes starting with 0011930, 0011931, and 0011941. A total of 7,044,680 units are involved in this recall, which affects products distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall was initiated after Zimmer reviewed 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 subsequent seal integrity testing showed that the packaging trays met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all unexpired lots that were sterile packaged in that specific facility to ensure patient safety.
Healthcare providers and patients should check their inventory and patient records for these specific item codes. If you have received or used these implants, contact your healthcare provider or Zimmer, Inc. for further instructions on how to proceed.
The recalled product
- Product
- VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item codes starting with 0011930, 0011931 and 0011941
- 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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