Recall Z-1314-2021— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1314-2021
Creator: U.S. Food and Drug Administration
Published: 2021-02-22

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2021-02-22, terminated 2023-10-11. It names one FDA 510(k) clearance: K170806. Product: ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.. Reason: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-02-22
Terminated: 2023-10-11
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K170806 — ATTUNE Cemented Tibial Base, Fixed BearingDepuy(Ireland)·cleared 2017-06-15

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

ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

Reason for recall

Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

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