ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacemen
FDA device recall Z-1456-2024 · posted 2024-03-29 · Open, Classified
Recall details
- Recalling firm
- DePuy Orthopaedics, Inc.
- Reason for recall
- Product incorrectly labelled.
- Action taken
- 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 records. Questions about this recall should be directed to the consignee's assigned DePuy Synthes Sales Consultant.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 5 units
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
- Date initiated
- 2024-03-12
- Date posted
- 2024-03-29
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K232303) | Depuy Ireland UC | 2023-12-11 |
| ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP (K213781) | Depuy Ireland UC | 2022-01-18 |
| ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology (K202194) | Depuy Ireland UC | 2020-11-25 |