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Zimmer Natural Nail System, Antegrade Femoral Targeting… recallZ-0376-2010 · Zimmer Inc. · initiated Jul 1, 2009

Terminated All recalls posted in November 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 guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.

FDA root cause category: Other

What the company is doing

On July 1, 2009, U.S. distributors were notified by e-mail to return two instruments. The recall was expanded with international accounts notified by e-mail on August 5, 2009, and U.S. accounts being notified by e-mail on August 6, 2009, to return 7 instruments. The scope of the recall was then expanded again to include 14 instruments and another letter dated September 14, 2009 to distributors and user accounts. The notifications described the affected products, problem, health risks and actions for consignees. Direct questions about the recall to Zimmer, Inc. by calling 1-800-613-6131.

Recall details

Recall number
Z-0376-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 1, 2009
Posted by the FDA
Nov 24, 2009
Recalling firm
Zimmer Inc.
Quantity
327 of total product
Product code
HSB
FDA submissions
K082770, K083497, K090596
Distribution
Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.

Product description

Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-05. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.

Code information (models, lots, serial numbers)

Lot 61221481.

Other devices under the same FDA submission

27 devices cleared under K082770, K083497, K090596 — 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 52806).

Sources and updates

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