Exactech Ergo Impactor Handle Recall: Ball and Spring May Dislodge
Exactech recalls Ergo Impactor Handle (Catalog #321-09-05) due to risk of ball and spring dislodging during use. Affected units include specific lot numbers and UDI-DI codes. Consumers should check their product details.
Use caution until it’s fixed
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
Contact the company
What happened, in plain English
Exactech is recalling its Ergo Impactor Handle (Catalog #321-09-05) because the ball and spring inside the locking mechanism can become dislodged during disassembly or use. This could lead to the handle failing unexpectedly, potentially causing injury. Read more at govinfonow.com/recall/57899-exactech-ergo-impactor-handle-recall-ball-and-spring-may-dislodge.
Source Summary by GovInfoNow · govinfonow.com/recall/57899-exactech-ergo-impactor-handle-recall-ball-and-spring-may-dislodge · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2051-2023
Cite this page
“Exactech Ergo Impactor Handle Recall: Ball and Spring May Dislodge.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57899-exactech-ergo-impactor-handle-recall-ball-and-spring-may-dislodge. Based on FDA recall #Z-2051-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2051-2023%22&limit=1).
Why it’s dangerous
The ball and spring inside the locking mechanism can become dislodged during disassembly or when the handle is used. This dislodging could cause the handle to fail unexpectedly, which might lead to injury.
Who’s affected
Users of the Exactech Ergo Impactor Handle with the specified catalog number and lot numbers are affected. People using this handle for impact applications are most at risk.
How to tell if you have this one
Check for the catalog number 321-09-05 on the handle. Affected units include specific lot numbers: 147544002, 275151004, 275151005, 275151006, 314934001, 400107002, 400798002, and additional lots added on 01/31/2025.
- Brand
Exactech- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2050-2023 | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.; Catalog #531-07-05 - Lot numbers: 154287001, 295878002, and 302331004; UDI-DI 10885862542038. | 250 devices |
| Z-2051-2023 | Exactech Ergo Impactor Handle, Catalog #321-09-05.; 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 | 784 devices |
What to do — step by step
Check Product Details
Identify the catalog number and lot numbers on your Exactech Ergo Impactor Handle to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 25 states and Puerto Rico, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Minnesota, Nevada, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Wisconsin.
Recall timeline
FDA published this recall 30 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this handle?
The recall does not require immediate stop use; however, you should check if your handle is affected before continuing use.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2051-2023 (June 5, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2051-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.