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Biomet Series A Standard Patella size 28mm, three pegs -… recallZ-0701-2012 · Biomet, Inc. · initiated Oct 4, 2011

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-0701-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 4, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
Biomet, Inc.
Product code
JWH
FDA submissions
K040770
Distribution
Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Argentina, Australia, Canada, Chile, Costa Rica, Europe, India, Japan, Korea, and Singapore.

Product description

Biomet Series A Standard Patella size 28mm, three pegs - 184762, 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.

Code information (models, lots, serial numbers)

Part 184762: Lot 107610, 136550, 205940, 205950, 205960, 205970, 248270, 248280, 248290, 344680, 344690, 344700, 369940, 369950, 403040, 423440, 423450, 474020, 184762 474030, 474040, 498270, 527680, 527690, 527700, 527710, 572160, 312080, 572170, 572180, 572190, 572200, 687900, 687910, 687920, and 687930

Other devices under the same FDA submission

17 devices cleared under K040770 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 60144).

Sources and updates

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