Recall Z-1456-2024 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
| Date | Mar 29, 2024 (initiated Mar 12, 2024) |
| Status | Open, Classified |
| Reason | Product incorrectly labelled. |
| Root cause | Process change control |
| Action | Consignees were hand-delivered an URGENT MEDICAL DEVICE RECALL REMOVAL notification, dated 3/11/24. The notice instructs consignees to examine their inventory for affected devices and quarantine them, contact their DePuy Synthes Sales Consultant to coordinate return of devices, and return the provided Business Response Form to OneMD-Field-Actions@its.jnj.com. If product was further distributed forward the provided notice. Forward the notice to anyone in the consignee facility that needs to be informed; the notice should be posted in a visible area for awareness and maintained in consignee reco |
| Quantity | 5 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Te Depuy Ireland UC, Nov 25, 2020 |
| K213781 | ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP Depuy Ireland UC, Jan 18, 2022 |
| K232303 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Tec Depuy Ireland UC, Dec 11, 2023 |