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Biomet CC Cruciate Tibial Tray, 67 mm recallZ-0706-2008 · Biomet, Inc. · initiated Dec 12, 2007

Terminated All recalls posted in January 2008

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: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.

FDA root cause category: Packaging process control

What the company is doing

Consignees were notified via an Urgent Medical Device Recall Notice dated 12/12/07 to cease use of the product and to return it.

Recall details

Recall number
Z-0706-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 12, 2007
Posted by the FDA
Jan 31, 2008
Recalling firm
Biomet, Inc.
Quantity
8
Product code
JWH
FDA submissions
K915132
Distribution
Worldwide: USA including states of Georgia, Idaho, Indiana, Missouri, Ohio, and Virginia and country of Turkey.

Product description

Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

Code information (models, lots, serial numbers)

Lot Number: 448530.

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 46141).

Sources and updates

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