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Recall Observatory FDA recall evidence

Device product

VER2 D8L OFFSET RASP HANDLE, RT Nonsterile

Z-2225-2014

July 23, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 68656
Status
Terminated
Classification
Class II
Quantity
412 units
Official record key
device-enforcement:Z-2225-2014

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 82016761302 Lot Number 97009564, 97009565, 97009570

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

    reason.no_named_rule · v1.0.0

    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.