Zimmer Inc. Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00. 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 ar Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-00. 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 ar
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 61219397, 61228025 and 61277887.
Products Sold
Lots 61219397, 61228025 and 61277887.
Zimmer Inc. is recalling Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile, Zimmer, due to The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes acc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026