Exactech Single Barrel Drill Guides Recalled for Incomplete Final Inspection
Exactech, Inc. is recalling two Single Barrel Drill Guides shipped to a single consignee in Florida before final inspection was 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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The specific hazard is a procedural failure (shipping before final inspection) rather than a confirmed defect causing injury, fitting the moderate severity criteria for voluntary precautionary or low-risk contamination/labeling issues.
Plain-English summary
Exactech, Inc. is recalling two units of the Single Barrel Drill Guide, a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. The specific units involved are identified by Catalog Number 05-109-14-0000 and Lot # 68266001.
The recall was initiated because the devices were shipped to a single consignee prior to the completion of final inspection. The distribution was limited to Florida.
No specific instructions for consumers or healthcare providers are provided in the source text regarding how to handle the recalled devices.
The recalled product
- Product
- Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 2
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 (2)
- Catalog Number 05-109-14-0000
- Lot # 68266001.
Distribution
Part of a larger recall action
This product is one of 2 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 2 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 · quality control failure
See all →- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighPreeclampsia growth factor assay recalled over out-of-range quality control values
FDA (Devices) · 2026-04-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- ModerateHeparin control material recalled after quality control results fell below acceptance range
FDA (Devices) · 2025-08-20