Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-03. 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.
This recall has been terminated (originally issued November 24, 2009).
- Company
- Zimmer Inc.
- Recall Initiated
- July 1, 2009
- Posted
- November 24, 2009
- Terminated
- October 5, 2011
- Recall Number
- Z-0379-2010
- Quantity
- 327 of total product
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
Lot / Code Info
Lots 61161122, 61175552, 61217393, 61248664 and 61233593.
Root Cause
Other
Action Taken
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.