Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-
Pending LLM rewrite. Source: FDA_DEVICE Z-1509-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Impactor handle may be missing cross-pin
The recalled product
- Product
- Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
- Manufacturer
- Exactech, Inc.
- Category
- Medical Device — Devices
Distribution
Distributed in 25 states:
- 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
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