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Custom Comprehensive Shoulder Bio-Modular Base, 44 mm… recallZ-0713-2011 · Biomet, Inc. · initiated Sep 13, 2010

Terminated All recalls posted in December 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 received complaints regarding fracturing of the device.

FDA root cause category: Pending

What the company is doing

The firm sent "URGENT MEDICAL DEVICE RECALL NOTICE" dated 9/13/2010 to their distributors and customers. The letters stated the reason for the recall and what may happen as a result of the fracture of the device. The notices stated that the recalled devices should be immediately located, discontinued from use, and shipped back to Biomet. Customers should follow the instructions on the "FAX Back Response Form." If the affected product was further distributed, hospital personnel must be notified of the recall via the enclosed "Dear Biomet Customer" notice. The firm sent "URGENT MEDICAL DEVICE RECALL NOTICES' to implanting surgeons. These letters informed the surgeons of the recall and instructed them to continue to monitor the patient for fracture of the device. Customers are to confirm receipt of the notice by calling 800-348-9500 ext 3755 or 3983. Questions should be directed to 574-371-3755 or 574-372-3983.

Recall details

Recall number
Z-0713-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 13, 2010
Posted by the FDA
Dec 16, 2010
Recalling firm
Biomet, Inc.
Quantity
45 both products
Product code
KWS
FDA submissions
K080642
Distribution
Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.

Product description

Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN Intended for total shoulder replacement in a reverse configuration.

Code information (models, lots, serial numbers)

Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100.

Other devices under the same FDA submission

46 devices cleared under K080642 — 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 57220).

Sources and updates

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