FDA recall Z-0074-2022

DePuy Orthopaedics, Inc. · Class II · device

Product

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

Distribution

US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.

Key facts

Status
Terminated
Initiation date
2021-09-09
Report date
2021-10-13
Termination date
2023-08-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0074-2022