Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices because labeling incorrectly states a ten-year shelf life instead of the qualified five-year limit.
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. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Exactech, Inc. has initiated a recall of Equinoxe Reverse Compression Screws, Replicator Plates, Locking Screws, Compression Screw Kits, Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices. The recall is due to a labeling error where the device packaging identifies the affected parts as having a ten-year shelf life, whereas the packaging configuration was only qualified for a five-year shelf life.
The recall involves 54,877 units distributed worldwide, including across the United States and in international markets such as Canada, the United Kingdom, and various European and Asian countries. The affected products are intended for primary and reverse total shoulder arthroplasty and intervertebral fusion.
Healthcare providers and patients should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this labeling discrepancy.
The recalled product
- Product
- Equinoxe Reverse Compression Screw 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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