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Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile… recallZ-2204-2010 · Biomet, Inc. · initiated Apr 20, 2010

Terminated All recalls posted in August 2010

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

A knee implant labeled as left was opened and the package actually contained a right knee implant.

FDA root cause category: Process control

What the company is doing

On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.

Recall details

Recall number
Z-2204-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 20, 2010
Posted by the FDA
Aug 10, 2010
Recalling firm
Biomet, Inc.
Quantity
5
Product code
JWH
FDA submissions
K023546
Distribution
1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan

Product description

Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.

Code information (models, lots, serial numbers)

M402080.

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

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