Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.
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 low-risk 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 is due to a labeling error where the devices are identified as having a ten-year shelf life, but the packaging configuration used is only qualified for a five-year shelf life.
The recall involves 54,877 units distributed worldwide, including the United States and various international locations. The affected products are intended for primary and reverse total shoulder arthroplasty and intervertebral fusion. The specific catalog number is 324-15-05, with a serial range of 1620549-2381151.
Healthcare providers and patients should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Equinoxe Reverse Glenosphere Locking Screw 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)
- Catalog Number 324-15-05 Serial Range 1620549-2381151
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
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