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Biomet OSS Elliptical Proximal Femoral Trial 7 cm left… recallZ-1531-2009 · Biomet, Inc. · initiated May 19, 2009

Terminated All recalls posted in June 2009

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

The retaining ring may fall out of the instrument during surgery.

FDA root cause category: Process control

What the company is doing

Distributors and consignees were notified by an Urgent Medical Device Recall Notice dated 5/19/09. Distributors and consignees were instructed to locate and remove the devices from circulation, carefully follow the instructions on the "FAX Back Response Form," and fax a copy of the Response Form to 574-372-1683 prior to return of the product. If the product has been further distributed, consignees must notify hospital personnel responsible for receiving recall notices of the action, via the enclosed "Dear Biomet Customer" notice. Consignees are responsible for the location and return of products to the firm. The letter stated that the instruments would be reworked and returned.

Recall details

Recall number
Z-1531-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 19, 2009
Posted by the FDA
Jun 29, 2009
Recalling firm
Biomet, Inc.
Quantity
387 of all products
Product code
KRO
FDA submissions
K002757, K043547
Distribution
Worldwide Distribution -- USA, Australia, Belgium, Canada, Costa Rica, Finland, France, Germany, Mexico, New Zealand, Poland, South Wales, and Spain.

Product description

Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical instrument for use with other devices in orthopedic surgery.

Code information (models, lots, serial numbers)

All lots. Lots 681420 and 989750.

Other devices under the same FDA submission

82 devices cleared under K002757, K043547 — 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 51980).

Sources and updates

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