Zimmer Recalls Versa-FX Orthopedic Implants Due to Packaging Validation Issues
Zimmer is recalling specific Versa-FX orthopedic implant lots because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 (FDA Class II) where seal integrity testing met acceptance criteria, and no illnesses or injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling specific lots of Versa-FX Keyless, Short Tube, Standard Tube, and Sprcndlr Tube orthopedic implants. The recall affects 7,044,680 units distributed worldwide, including the United States and numerous international markets. The affected products are identified by specific item codes starting with 001980, 001981, 0011990, and 0011991.
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 met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility to ensure safety.
Healthcare providers and patients should check their inventory and medical records for these specific item codes. If you have received these implants, contact your healthcare provider or Zimmer for further instructions on how to proceed.
The recalled product
- Product
- VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with…
- 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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