FDA-Device2023-07-05Class II
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Exactech, Inc.
Hazard
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Sold states
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.
Affected count
250 devices
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2023Don't want to check this manually?
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