—#74311

Product

Biomet Vanguard(TM) DCM PS Plus 16mm x 63/67mm Tibial Bearing (REF. 183726), ARCOM UHMWPE, sterile, Biomet Orthopedics, Inc., Warsaw, IN. A knee prosthesis intended for single use implantation to replace the articular portions of the knee joint.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K041046
Affected lot / code info: Lots 713910, 806560, 816560 and 871750.

Why it was recalled

The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".

Root cause (FDA determination)

Process control

Action the firm took

A notification letter (Urgent Medical Device Removal Notice) dated 9/22/08 was sent to the firm's sales staff with instructions to locate and retrieve the product and to notify customers at affected hospitals of the problem. Questions related to this notice should be directed to the Biomet Orthopedics, LLC Corrective Actions Manager at 800-348-9500 or 574-372-3983, Monday through Friday, 8 A.M. to 5 P.M. (EST).

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Worldwide Distribution: USA including states of Florida, New Jersey, Maryland, Pennsylvania, South Carolina, South Dakota, and Virginia, and country of Finland.

Timeline

Recall initiated: 2008-09-22
Posted by FDA: 2008-11-21
Terminated: 2009-09-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74311. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.