Recall Z-0387-2010 · HSB Rod, Fixation, Intramedullary And Accessories

Zimmer Inc.

Zimmer Natural Nail System, Tibial Module, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-005-04. 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 proxim

Date	Nov 24, 2009 (initiated Jul 1, 2009)
Status	Terminated
Reason	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.
Root cause	Other
Action	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.
Quantity	327 of total product
Distribution	Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
FDA record	Open on fda.gov

510(k) clearances named in this recall

K082770	ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL Zimmer, Inc., Dec 11, 2008
K083497	ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS Zimmer, Inc., Feb 19, 2009
K090596	ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM Zimmer, Inc., Jun 30, 2009