Recall Z-2219-2014— Zimmer, Inc.

Name: FDA recall Z-2219-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-23

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-23, terminated 2015-09-15. FDA's recall record names no specific 510(k) clearance for this event. Product: VI DBL OFFST W/ LRG STPL, LT Nonsterile. Reason: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-23
Terminated: 2015-09-15
Firm location: Warsaw, IN, United States

Product description

VI DBL OFFST W/ LRG STPL, LT Nonsterile

Reason for recall

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Data sourced from openFDA. This site is unofficial and independent of the FDA.