Device product
VI DBL OFFST W/ LRG STPL, LT Nonsterile
Z-2219-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68656
- Status
- Terminated
- Classification
- Class II
- Quantity
- 412 units
- Official record key
device-enforcement:Z-2219-2014
Official wording
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.
Code information: Item Number 82016757841 Lot Number 97009219, 97009254
Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
Derived failure modes
-
Unknown
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.