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Open, Classified

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

FDA Recall Z-1778-2022 · Posted 2022-09-23

Recalling FirmHowmedica Osteonics Corp.
Recall StatusOpen, Classified
Product CodeKRQ
Date Initiated2022-08-24
Product Quantity1 unit

Reason for Recall

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.

Firm Action

On August 24, 2022, the firm sent written notification (Product Field Action) to the single affected customer to document the event. The customer was asked to confirm their receipt of the notice.

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed to one customer located in New York.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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