—#67991

Product

Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K023546
Affected lot / code info: Lot 743470.

Why it was recalled

Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.

Root cause (FDA determination)

Packaging process control

Action the firm took

Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46581-0587

Distribution

Distribution pattern: Worldwide: USA and Australia

Timeline

Recall initiated: 2008-02-12
Posted by FDA: 2008-07-25
Terminated: 2009-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67991. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.