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Comprehensive reverse shoulder humeral tray with locking… recallZ-2543-2011 · Biomet, Inc. · initiated Apr 22, 2011

Terminated All recalls posted in June 2011

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 is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

FDA root cause category: Employee error

What the company is doing

The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580. Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.

Recall details

Recall number
Z-2543-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 22, 2011
Posted by the FDA
Jun 9, 2011
Recalling firm
Biomet, Inc.
Quantity
1575 all products
Product code
KWS
FDA submissions
K080642
Distribution
Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and Netherlands.

Product description

Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

Code information (models, lots, serial numbers)

M132050, M153460, M310650, M372360, M372370, M402160, M424790, M451890, M696360, M717580, M717590, M908060 and M926990.

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 58571).

Sources and updates

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