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Zimmer Coonrad/Morrey total elbow cement restrictor with… recallZ-1700-2009 · Zimmer Inc. · initiated Jun 8, 2009

Terminated All recalls posted in July 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 seal on the sterile barrier pouch may be inadequate, resulting in lack of assurance of sterility.

FDA root cause category: Packaging process control

What the company is doing

Zimmer Orthopedic Surgical Products issued an "Urgent: Medical Device Recall" notice dated June 8, 2009 informing users of the affected devices and actions to be taken including the return of product and acknowledgement of receipt of notice by returning the Recall Certification Form by fax to 1-330-364-0974.

Recall details

Recall number
Z-1700-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 8, 2009
Posted by the FDA
Jul 23, 2009
Recalling firm
Zimmer Inc.
Quantity
110
Product code
JDI
FDA submissions
K040389
Distribution
Worldwide Distribution -- United States, Canada and Japan.

Product description

Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800. Total joint arthroplasy to control, restrict or impede the flow of cement. Larger plugs are useful in revision surgery where a wide, smooth Imtramedullary canal must be plugged.

Code information (models, lots, serial numbers)

Lot Numbers: 61249897 and 61249899.

Other devices under the same FDA submission

1 device cleared under K040389 — 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 52227).

Sources and updates

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