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Zimmer Trilogy Acetabular System Shell with Cluster Holes… recallZ-0620-2008 · Zimmer Inc. · initiated Oct 19, 2007

Terminated All recalls posted in March 2008

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

Parts missing and incomplete etch: The units may not contain the locking ring or the etched alignment marks on the rim.

FDA root cause category: Process control

What the company is doing

Zimmer sent consignees a Product Recall Notification letter dated 10/19/07, requiring them to return the product.

Recall details

Recall number
Z-0620-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 19, 2007
Posted by the FDA
Mar 19, 2008
Recalling firm
Zimmer Inc.
Quantity
31
Product code
LPH
FDA submissions
K934765
Distribution
Worldwide Distribution - USA (Arizona, California, Delaware, Indiana, Iowa, Kansas, Massachusetts, New York, Ohio, Pennsylvania, South Carolina, Texas, and Wisconsin), Australia, Canada, Germany, Italy, and Spain.

Product description

Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, 46580.

Code information (models, lots, serial numbers)

Lot Number: 26208600; exp. 2013-02.

Other devices under the same FDA submission

8 devices cleared under K934765 — 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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