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Zimmer Trabecular Metal Reverse Shoulder System… recallZ-1417-06 · Zimmer Inc. · initiated Jul 20, 2006

Terminated All recalls posted in August 2006

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

Components may not lock together as intended.

FDA root cause category: Other

What the company is doing

Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.

Recall details

Recall number
Z-1417-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 20, 2006
Posted by the FDA
Aug 26, 2006
Recalling firm
Zimmer Inc.
Quantity
197 for all three recalls Z-1416-1418-06
Product code
KWT
FDA submissions
K052906
Distribution
Worldwide distribution --- USA and countries of Australia and China

Product description

Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.

Code information (models, lots, serial numbers)

All lots.

Other devices under the same FDA submission

34 devices cleared under K052906 — 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 35942).

Sources and updates

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