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Recall Observatory FDA recall evidence

Device product

Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

Z-2227-2014

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-2227-2014

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 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896

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.