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Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and recallZ-0227-2013 · Zimmer, Inc. · initiated Sep 4, 2012

Class II Terminated All recalls posted in November 2012

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

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

FDA root cause category: Error in labeling

What the company is doing

Zimmer, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Certificate of Acknowledgement Form was attached for customers to complete and return via fax to Zimmer, Inc. at 574 372-4265.

Recall details

Recall number
Z-0227-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 4, 2012
Posted by the FDA
Nov 6, 2012
Recalling firm
Zimmer, Inc.
Quantity
45 USA
Product code
KWS
FDA submissions
K030259, K062029
Distribution
Nationwide Distribution.

Product description

Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem

Code information (models, lots, serial numbers)

REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901,  2435527, 2398475

Other devices under the same FDA submission

4 devices cleared under K030259, K062029 — 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 63103).

Sources and updates

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