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Zimmer brand Coonrad/Morrey total elbow interchangeable… recallZ-0767-04 · Zimmer Inc. · initiated Mar 16, 2004

Terminated All recalls posted in July 2004

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

Right ulna implants were etched and labeled as left ulna implants. Left ulna implants may have been etched and labeled as right ulna implants.

FDA root cause category: Other

What the company is doing

Consignees were notified via e-mail on 3/16/04. Consignees were asked to secure their inventory from use and to notify all customers if they had further distributed the product. Product shipped to Japan and Singapore was contained prior to shipment to hospitals.

Recall details

Recall number
Z-0767-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 16, 2004
Posted by the FDA
Jul 20, 2004
Recalling firm
Zimmer Inc.
Product code
JDC
FDA submissions
K001989
Distribution
United States, Australia, Canada, Finland, France, Germany, Israel, Italy, Japan, Korea, Singapore, Spain, and the United Kingdom.

Product description

Zimmer brand Coonrad/Morrey total elbow interchangeable ulnar assembly, small, left, 3 in. length. tivanium TI-6AL-4V alloy/UHMWPE, sterile, for use with bone cement. Cat. no. 32-8105-53-01.

Code information (models, lots, serial numbers)

Lot 60039452.

Other devices under the same FDA submission

13 devices cleared under K001989 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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