Recall Z-1778-2022— Howmedica Osteonics Corp.

Name: FDA recall Z-1778-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-24

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2022-08-24. It names one FDA 510(k) clearance: K140898. Product: Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.. Reason: 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..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-08-24
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K140898 — PATIENT SPECIFIC DISTAL FEMORALStanmore Implants Worldwide , Ltd.·cleared 2015-01-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.