FDA Device recall Z-1314-2021

ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace t…

FDA Device
Class II
terminated
Published 2021-04-07

On 2021-04-07 the FDA classified a Class II recall of ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace t… by Depuy Orthopaedics, citing 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 A….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1314-2021
Classification	Class II
Status	terminated
Initiated	2021-02-22
Published	2021-04-07
Last updated	2026-09-13 11:56 UTC
Company	Depuy Orthopaedics
Distribution	US

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.

Identifiers

code_info	Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 1060329549206… Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061 Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078 Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078 Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085 Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092 Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108 Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108 Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115

code_info

Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 1060329549206…

Lot#: 9558300, Product Code: 150670003, GTIN 10603295492054 Lot#: 9555958, Product Code: 150670004, GTIN 10603295492061 Lot#: 9554006, Product Code: 150670005, GTIN 10603295492078 Lot#: 9556397, Product Code: 150670005, GTIN 10603295492078 Lot#: 9558618, Product Code: 150670006, GTIN 10603295492085 Lot#: 9557992, Product Code: 150670007, GTIN 10603295492092 Lot#: 9558238, Product Code: 150670008, GTIN 10603295492108 Lot#: 9558239, Product Code: 150670008, GTIN 10603295492108 Lot#: 9555613, Product Code: 150670009, GTIN 10603295492115

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2021%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.