Exactech Ergo Impactor Handle — Class II medical device recall Z-2051-2023
Ongoing recall by Exactech, Inc., reported 2023-07-05, distributed in AR, CA, CO, FL, GA, HI, ID, IL…. The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or durin
| Recall number | Z-2051-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2023-06-05 |
| Classified | 2023-06-30 |
| Reported by FDA | 2023-07-05 |
| Distributed | 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 |
| Countries outside the US | AU, FR, JP |
| Quantity | 784 devices |
| UPC / GTIN / UDI-DI | 10885862557674 |
| Lot numbers | 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, 400798002, 401819005, 401819007, 401819008, 404552002, 405253003, 405492002, 406041001 |
| Model numbers | 321-09-05 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2051-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.