Z-0074-2022 Class II Terminated
FDA device recall Z-0074-2022 was initiated by DePuy Orthopaedics, Inc. on September 9, 2021 and is designated Class II. Reason for recall: Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery The recall status is terminated (terminated August 9, 2023). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- September 9, 2021
- Termination Date
- August 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
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
Distribution Pattern
US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
Code Information
Lot Number: J6304Z GTIN: 10603295057642