—#206599

Product

ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

FDA product code: MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K202194, K213781, K232303
Affected lot / code info: Model No: 150621006; UDI-DI: 10603295507451; Lot JA06A0252.

Why it was recalled

Product incorrectly labelled.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.

Timeline

Recall initiated: 2024-03-12
Posted by FDA: 2024-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.