—#105833

Product

Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. 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 184782: Lot 098970, 144970, 190440, 232540, 274550, 357320, 397810, 397820, 438790, 438800, 498310, 539710, 599220, 644430, 710240

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 #105833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.