ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Recall
- Recall Number
- Z-1456-2024
- Event Number
- 94222
- Firm
- DePuy Orthopaedics, Inc.
- FEI Number
- 1818910
- Product Code
- MBH
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- March 12, 2024
- Posted
- March 29, 2024
- Address
- 700 Orthopaedic Dr, Warsaw, IN, 46582-3994
Description
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
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 [email protected]. 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.
Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
5 units