Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Label reading in part as: "NexGen System Recalled by Zimmer Manufacturing B.V. Due to Complaints were received from Thailand reporting that there...
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 Manufacturing B.V. directly.
Affected Products
Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component to perform knee arthroplasty.
Quantity: 179
Why Was This Recalled?
Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264
Where Was This Sold?
US Distribution and the country of Thailand.
About Zimmer Manufacturing B.V.
Zimmer Manufacturing B.V. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report