Equinoxe Ergo Ergo Modular Impactor Handle Recall: Missing Cross-Pin Hazard
Exactech recalls Equinoxe Ergo Ergo Modular Impactor Handles with model 321-09-05 due to potential missing cross-pin. Affected units may require repair or replacement.
Lower-risk recall
Impactor handle may be missing cross-pin
Contact the company
What happened, in plain English
Exactech recalls Equinoxe Ergo Ergo Modular Impactor Handles with model number 321-09-05 because the impact handle may have a missing cross-pin. This could cause the tool to fail during use, potentially leading to injury. Read more at govinfonow.com/recall/50053-equinoxe-ergo-ergo-modular-impactor-handle-recall-missing-cross-pin.
Source Summary by GovInfoNow · govinfonow.com/recall/50053-equinoxe-ergo-ergo-modular-impactor-handle-recall-missing-cross-pin · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1509-2026
Cite this page
“Equinoxe Ergo Ergo Modular Impactor Handle Recall: Missing Cross-Pin Hazard.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50053-equinoxe-ergo-ergo-modular-impactor-handle-recall-missing-cross-pin. Based on FDA recall #Z-1509-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1509-2026%22&limit=1).
Why it’s dangerous
The impact handle may have a missing cross-pin, which can cause the tool to become unstable or fail during use. This could lead to the tool slipping or breaking, potentially causing injury to the user.
Who’s affected
Users of the Equinoxe Ergo Ergo Modular Impactor Handle with model 321-09-05 are affected. Workers using this tool for impact tasks are most at risk if the cross-pin is missing.
How to tell if you have this one
Check for the model number 321-09-05 on the handle. All units with this model number are affected, as indicated by the lot code and part number.
- Brand
Equinoxe Ergo- 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
US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1509-2026 | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05; Lot Code: Part Number: 321-09-05 UDI-DI: 10885862557674 Lot Number: All (Please refer to Attachment 1 - Product Information Spreadsheet for details) | 120 units |
| Z-1510-2026 | Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X; All Lots/ UDI-DI: 10885862559166 | 596 kits |
What to do — step by step
Check for Missing Cross-Pin
Inspect the impact handle for a missing cross-pin. If found, stop using the handle immediately.
Where it went and when
Where it was distributed
Distributed in 24 states and Puerto Rico, and outside the U.S.
FDA distribution: “US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 43 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.
Similar recalls
Latest medical device recalls
Keep exploring
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-1509-2026 (February 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1509-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 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.