KRQClass IIImplant

Prosthesis, Knee, Patello/femorotibial, Constrained, Cemented, Polymer/metal/polymer

Orthopedic · 21 CFR 888.3550

MDR events3All time

Recalls1All time

Registered firms26Currently listed

510(k) clearances0All time

Recent MDR events

3 adverse event reports on file

Event type breakdown

Injury3

Most-reported manufacturers

Biomet, Inc.2 Biomet Inc1 Biomet, Inc1 Zimmer, Inc.1

Recalls

1 recall events for this product code

Howmedica Osteonics Corp.
Open, ClassifiedSep 23, 2022
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
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.
Z-1778-2022 · View FDA record ↗

Registered firms

26 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.