Zimmer Recalls Natural Knee II Revision Femoral Stems Due to Sterility Breach
Zimmer, Inc. is recalling 352 Natural Knee II Revision Femoral Stems because a breach in the sterile barrier could lead to periprosthetic infection.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (periprosthetic infection) for a medical device where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer, Inc. is recalling 352 units of the Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185, packaged in configuration 803/791. The recall affects specific lots of this knee prosthesis component distributed nationwide, including DC and 31 states.
The recall was initiated because the product failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is also compromised, a periprosthetic infection may occur. The risk associated with such an infection is the need for a revision or potential multi-stage revision to treat the infection.
Healthcare providers and facilities should identify and quarantine the affected lots. Consumers who have had this specific component implanted should contact their healthcare provider for guidance.
The recalled product
- Product
- Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 352
Distribution
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