FDA-Device2023-07-05Class II
Exactech Ergo Impactor Handle, Catalog #321-09-05.
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
784 devices
Manufactured in
2320 Nw 66th Ct, N/A, Gainesville, FL, United States
Products
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2051-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief