Exactech Equinoxe Reamer Recall Due to Updated Instructions for Use
Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
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: The recall is classified as FDA Class II but is driven by a documentation update (IFU) to clarify technique and prevent instrument breakage, fitting the 'Minor labeling errors' or 'documentation issues' criteria for a Moderate severity score.
Plain-English summary
Exactech, Inc. is recalling 198 units of the EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer (Catalog #s 321-45-38, 321-45-42, and 321-45-46). The recall is initiated to update the Instructions for Use (IFU) to clarify the proper technique and instrumentation for reaming the Glenoid.
The updated IFU includes a caution statement advising surgeons to ream on-axis, noting that reaming off-axis may result in instrument breakage. The affected units were distributed to 32 U.S. states, Puerto Rico, and 20 international countries.
This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
- Manufacturer
- Exactech, Inc.
- Affected units
- 198
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 (1)
- All Lots
Distribution
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModeratePilot tip converters 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
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · instrument breakage
See all →- HighDriver Instrument May Break During Surgery, Leaving Metal Fragments
FDA (Devices) · 2023-06-21
- SevereK2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
FDA (Devices) · 2020-05-27
- HighStryker Recalls Thoracic Pedicle Feelers Due to Potential Tip Breakage
FDA (Devices) · 2018-04-04
- HighExactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming
FDA (Devices) · 2017-07-12
- ModerateExactech Equinoxe Reverse Starter Reamer Recalled for Updated Instructions
FDA (Devices) · 2017-07-12