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Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with… recallZ-0255-2008 · Biomet, Inc. · initiated Sep 18, 2007

Terminated All recalls posted in November 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: the package actaully contained a 71 mm tray.

FDA root cause category: Labeling mix-ups

What the company is doing

Consignees were notified via letter dated 9/18/07 to discontinue use of the product and to return it to the firm.

Recall details

Recall number
Z-0255-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 18, 2007
Posted by the FDA
Nov 24, 2007
Recalling firm
Biomet, Inc.
Quantity
7
Product code
JWH
FDA submissions
K915132
Distribution
Nationwide : Distributors in Georgia, Kentucky, Texas and Washington.

Product description

Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582

Code information (models, lots, serial numbers)

Lot 626520.

Other devices under the same FDA submission

48 devices cleared under K915132 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page