Recall Z-0074-2022— DePuy Orthopaedics, Inc.

Name: FDA recall Z-0074-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-09

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2021-09-09, terminated 2023-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001. Reason: Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery.

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-09-09
Terminated: 2023-08-09
Firm location: Warsaw, IN, United States

Product description

ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

Reason for recall

Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

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