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FDAAugust 24, 2022device

Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

howmedica osteonicshowmedica

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component. — Recall Details · AllClear