Device product
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Z-2231-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 68656
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2231-2014
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 82-0167-636-20 Lot Number 97009531, 97009781
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.