Recall Z-1456-2024— DePuy Orthopaedics, Inc.
Class II · Ongoing
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2024-03-12. It names 3 FDA 510(k) clearances: K232303, K213781, K202194. Product: ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.. Reason: Product incorrectly labelled..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-12
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
3 on FDA's record- K232303 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
- K213781 — ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP
- K202194 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology
K-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 AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Reason for recall
Product incorrectly labelled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.