Pilot tip converters recalled after release without completed performance testing
Exactech is recalling one Equinoxe Ergo Augments Pilot Tip Converter because it was released before design updates and performance testing were completed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites release before testing was completed rather than a confirmed defect or reported harm.
Plain-English summary
The Exactech Equinoxe Ergo Augments Pilot Tip Converter, catalog number 301-11-11, is being recalled.
The recall follows products that have not completed design updates and performance testing being released and distributed. The firm states the products may not conform to design and performance criteria.
The recall covers 1 unit carrying UDI 10885862592934, from lot 410413-001, distributed in South Carolina. The FDA has classified the action as Class II.
The enforcement record cites the incomplete testing without describing a confirmed nonconformance or health consequence, and reports no injuries. Facilities holding the affected lot should follow Exactech's instructions.
The recalled product
- Product
- Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
- Manufacturer
- Exactech, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Code: Part Number: 301-11-11
- UDI: 10885862592934
- Lot Number: 410413-001
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- HighShoulder humeral liners recalled over articular surface outside dimensional specification
FDA (Devices) · 2025-09-24
Same hazard · incomplete testing
See all →- SevereOn-X Mitral Heart Valve Model ONXMC-25/33 Released Without Complete Testing
FDA (Devices) · 2026-05-20
- HighInfusion pumps recalled after being released without full testing
FDA (Devices) · 2026-02-25
- HighBaxter Infusion Pump Recalled for Incomplete Post-Repair Testing
FDA (Devices) · 2025-01-08
- HighBaxter SIGMA Spectrum Infusion Pump Recalled for Incomplete Post-Repair Testing
FDA (Devices) · 2025-01-08
- HighMedX Lumbar Extension Machines Recalled for Incomplete Safety Testing
FDA (Devices) · 2015-01-14