[pending] Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-
Pending LLM rewrite. Source: FDA_DEVICE Z-1509-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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