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Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR… recallZ-1375-2008 · Biomet, Inc. · initiated Feb 12, 2008

Terminated All recalls posted in July 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: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.

FDA root cause category: Packaging process control

What the company is doing

Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.

Recall details

Recall number
Z-1375-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 12, 2008
Posted by the FDA
Jul 25, 2008
Recalling firm
Biomet, Inc.
Quantity
4
Product code
JWH
FDA submissions
K023546
Distribution
Worldwide: USA and Australia

Product description

Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.

Code information (models, lots, serial numbers)

Lot 743430.

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 46708).

Sources and updates

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