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Recall Observatory FDA recall evidence

Device product

Drill, cannulated, 4x90mm, round shaft, Item Number 502015640

Z-1450-2019

April 08, 2019

Class II

Product summary

Firm
Zimmer GmbH
Event
Event 82642
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1450-2019

Official wording

Reason: An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.

Code information: All items marked with "Normed" are affected

Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.