Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Natural Knee II Revision Femoral Stem Recalled by Zimmer, Inc. Due to Failed to meet established requirements for sterile barrier...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.
Affected Products
Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component.
Quantity: 352
Why Was This Recalled?
Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or potential multi-stage revision to treat the infection.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zimmer, Inc.
Zimmer, Inc. has 437 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report