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Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar… recallZ-1056-2009 · Zimmer Inc. · initiated Jan 30, 2009

Terminated All recalls posted in April 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 Zimmer 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 surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.

FDA root cause category: Labeling design

What the company is doing

Consignees were notified by "Urgent Device Correction" letter dated January 30, 2009 and provided revised surgical techniques for these extra-small implants. Direct questions about this recall to Zimmer, Inc. at 574-267-6131.

Recall details

Recall number
Z-1056-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 30, 2009
Posted by the FDA
Apr 2, 2009
Recalling firm
Zimmer Inc.
Quantity
14,613 of all products
Product code
JDC
FDA submissions
K053189
Distribution
Worldwide Distribution, including USA, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.

Product description

Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile, Zimmer, Warsaw, IN; REF 32-8105-043-02. The device is utilized for a total elbow arthroplasty surgical procedure.

Code information (models, lots, serial numbers)

All lots.

Other devices under the same FDA submission

2 devices cleared under K053189 — 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 50914).

Sources and updates

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