FDA Device recall Z-2051-2023
Exactech Ergo Impactor Handle, Catalog #321-09-05
- FDA Device
- Class II
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class II recall of Exactech Ergo Impactor Handle, Catalog #321-09-05 by Exactech, citing the ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2051-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-05 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, ME, MN, NH, NV, NY, OH, OK, PA, PR, SC, TN, TX, WI |
Product
Exactech Ergo Impactor Handle, Catalog #321-09-05.
Reason
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Identifiers
| code_info | Catalog #321-09-05 - Lot numbers: 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, and 400798002; UDI…Catalog #321-09-05 - Lot numbers: 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, and 400798002; UDI-DI 10885862557674. Updated data - 01/31/2025: Additional Lot Numbers 401819005 401819007 401819008 404552002 405492002 405253003 406041001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2051-2023%22
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