PlainRecalls
FDA Devices Moderate Class II Ongoing

Exactech Ergo Impactor Handle, Catalog #321-09-05.

Reported: July 5, 2023 Initiated: June 5, 2023 #Z-2051-2023

Product Description

Exactech Ergo Impactor Handle, Catalog #321-09-05.

Reason for Recall

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

Details

Recalling Firm
Exactech, Inc.
Units Affected
784 devices
Distribution
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.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
Exactech Ergo Impactor Handle, Catalog #321-09-05.. Recalled by Exactech, Inc.. Units affected: 784 devices.
Why was this product recalled?
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 5, 2023. Severity: Moderate. Recall number: Z-2051-2023.