Recall archive / FDA device enforcement
Exactech Ergo Impactor Handle, Catalog #321-09-05. — FDA record Z-2051-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 5, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Exactech, Inc.
- Quantity
- 784 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2051-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 5, 2023
- Recall initiation date
- Jun 5, 2023
- Center classification date
- Jun 30, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.