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Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR… recallZ-2945-2011 · Biomet, Inc. · initiated Jul 6, 2011

Terminated All recalls posted in August 2011

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

The recalled device was manufactured with two distal pegs but package labeling indicates the device is pegless.

FDA root cause category: Employee error

What the company is doing

Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to quarantine and return the devices, and a return form. For information or questions on this recall call Biomet at (574) 371-3756.

Recall details

Recall number
Z-2945-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 6, 2011
Posted by the FDA
Aug 4, 2011
Recalling firm
Biomet, Inc.
Quantity
8
Product code
JWH
FDA submissions
K023546
Distribution
Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.

Product description

Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.

Code information (models, lots, serial numbers)

Part # 183132.  Lot # 947480.

Other devices under the same FDA submission

52 devices cleared under K023546 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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