Exactech Recalls Equinoxe 44mm Short Humeral Head Shoulder Implants
Exactech, Inc. is recalling 112 Equinoxe 44mm Short Humeral Head shoulder implant components because incorrect outer and inner labeling may misidentify the device size.
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 corresponds to a moderate severity level. The hazard is a labeling error that could lead to the use of an incorrect device size, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Exactech, Inc. is recalling 112 Equinoxe 44mm Short Humeral Head orthopedic shoulder implant components, catalog number 310-01-44. The recall is due to incorrect packaging where the outer and inner labeling may incorrectly identify the size of the enclosed device.
The affected devices are identified by serial numbers 3597678 through 3597713, 3609323 through 3609358, 3616214 through 3616249, and 3640539 through 3640574. These devices were distributed worldwide, including nationwide in the United States in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA, and WA, as well as in Brazil and Canada.
Healthcare providers and facilities should check their inventory for these specific serial numbers and stop using the affected devices. Patients who have already received these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 112
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)
- Serial Numbers 3597678 thru 3597713
- 3609323 thru 3609358
- 3616214 thru 3616249 and 3640539 thru 3640574.
Distribution
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 · mis labeling
See all →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02