Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding shelf life, which is a moderate risk compared to direct physical defects or contamination.
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 involves 54,877 units distributed worldwide, including the United States and various international locations.
The recall was initiated because the firm determined that the device labeling identifies the affected parts as having a ten-year shelf life. However, the packaging configuration used for these devices was only qualified to a five-year shelf life. This discrepancy between the labeled shelf life and the qualified shelf life is the reason for the recall.
The affected products are intended for primary and reverse total shoulder arthroplasty. The recall includes specific sizes and catalog numbers: 1.5 mm (Catalog Number 300-10-15, Serial Range 1653131-2381151) and 4.5 mm (Catalog Number 300-10-45, Serial Range 1622046-2381151). Consumers and healthcare providers should check their inventory for these specific serial ranges and contact Exactech for further instructions.
The recalled product
- Product
- Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 54,877
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
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Similar recalls
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FDA (Devices) · 2020-10-07
- ModerateExactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling
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