RecallDepth

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

Company
Howmedica Osteonics Corp.
Recall Initiated
August 24, 2022
Posted
September 23, 2022
Recall Number
Z-1778-2022
Quantity
1 unit
Firm Location
Mahwah, NJ

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.

Distribution

Distributed to one customer located in New York.

Lot / Code Info

Lot number B24694 (no UDI)

Root Cause

Under Investigation by firm

Action Taken

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.

More recalls by Howmedica Osteonics Corp.

View all recalls by this company →