—#195986

Product

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

FDA product code: KRQ — Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K140898
Affected lot / code info: Lot number B24694 (no UDI)

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Distributed to one customer located in New York.

Timeline

Recall initiated: 2022-08-24
Posted by FDA: 2022-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.