Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Short tibial bearing MK4 - Std Recalled by Howmedica Osteonics Corp. Due to A MK4 Tibial Bearing was supplied with the...
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 Howmedica Osteonics Corp. directly.
Affected Products
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Quantity: 1 unit
Why Was This Recalled?
A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.
Where Was This Sold?
Distributed to one customer located in New York.
About Howmedica Osteonics Corp.
Howmedica Osteonics Corp. has 229 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report