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Recall Observatory FDA recall evidence

Device product

Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.

Z-2050-2023

June 05, 2023

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 92414
Status
Ongoing
Classification
Class II
Quantity
250 devices
Official record key
device-enforcement:Z-2050-2023

Official wording

Reason: The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.

Code information: Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038.

Distribution pattern: Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, SC, TN, TX, WI, as well as PR. There was no government/military distribution. Foreign distribution was made to Australia, France, and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.