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Mallory Head Calcar Femoral 55 mm resection/porous coated… recallZ-1675-2010 · Biomet, Inc. · initiated Mar 10, 2010

Terminated All recalls posted in May 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

The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep.

FDA root cause category: Process change control

What the company is doing

Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM.

Recall details

Recall number
Z-1675-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 10, 2010
Posted by the FDA
May 26, 2010
Recalling firm
Biomet, Inc.
Quantity
6
Product code
LPH
FDA submissions
K031693
Distribution
Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands.

Product description

Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Sterile, REF 11-104972, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.

Code information (models, lots, serial numbers)

Lot Number: M472000.

Other devices under the same FDA submission

2 devices cleared under K031693 — 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 55365).

Sources and updates

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