Recall Z-2348-2021— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2021-07-01, terminated 2023-02-01. It names one FDA 510(k) clearance: K160700. Product: ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080. Reason: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement.
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-01
- Terminated
- 2023-02-01
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Reason for recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Data sourced from openFDA. This site is unofficial and independent of the FDA.