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Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm… recallZ-0123-2008 · Biomet, Inc. · initiated Aug 31, 2007

Terminated All recalls posted in December 2007

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

Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.

FDA root cause category: Packaging process control

What the company is doing

Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.

Recall details

Recall number
Z-0123-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 31, 2007
Posted by the FDA
Dec 5, 2007
Recalling firm
Biomet, Inc.
Quantity
16
Product code
JWH
FDA submissions
K023546
Distribution
Nationwide.

Product description

Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581

Code information (models, lots, serial numbers)

Lot Number: 395450.

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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