—#105817

Product

Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582 Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For use with Vanguard, Maxim, Ascent & ACG knee system. Knee joint replacement prosthesis, intended for patella replacement of the knee joint in conjunction with a femoral and tibial component.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040770
Affected lot / code info: Part 184700: Lot 079520, 118810, 136470, 190350, 232400, 248190, 332290, 517200, 572130, 732770

Why it was recalled

Correcting language on product labeling which incorrectly states patella buttons are intended for use with the AGC knee system.

Root cause (FDA determination)

Error in labeling

Action the firm took

Biomet sent a "FIELD CORRECTION NOTICE" dated October 3, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate the affected product and to follow the work instructions included in the letter. Additionally, a Confirmation of Completion Response Form was enclosed for customers to complete and return via fax to 574-372-1683. Questions related to this notice are directed to 574-371-3755.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.

Timeline

Recall initiated: 2011-10-04
Posted by FDA: 2012-01-11
Terminated: 2013-04-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.