Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling error regarding shelf life, which fits the rubric for moderate severity involving minor labeling errors or voluntary precautionary recalls without reported injuries.
Plain-English summary
Exactech, Inc. has initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices. The recall was initiated because the firm determined that the device labeling identifies the affected parts as having a ten-year shelf life, whereas the packaging configuration used was only qualified to a five-year shelf life.
The recall involves 54,877 units distributed worldwide, including the United States and international locations such as Austria, Luxembourg, Sweden, Germany, Spain, France, Greece, Italy, the Netherlands, the United Kingdom, Canada, India, Australia, Switzerland, and São Paulo. The affected products are intended for primary and reverse total shoulder arthroplasty.
Consumers and healthcare providers should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 54,877
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)
- Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateExactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling
FDA (Devices) · 2018-02-07
- ModerateExactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components
FDA (Devices) · 2018-02-07
- HighExactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits
FDA (Devices) · 2020-10-07
- ModerateExactech Equinoxe Humeral Stem Recalled for Incorrect Label Translation
FDA (Devices) · 2020-02-05
- ModerateExactech Recalls Equinoxe 44mm Short Humeral Head Shoulder Implants
FDA (Devices) · 2015-04-29
- ModerateExactech Equinoxe Shoulder Arthroplasty Components Recalled for Defective Packaging
FDA (Devices) · 2024-04-10