Exactech Recalls Orthopedic Devices Due to Incorrect Shelf Life Labeling
Exactech is recalling specific orthopedic implants because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.
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, but the hazard is a labeling error regarding shelf life rather than a direct contamination or structural defect causing immediate injury, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Exactech, Inc. has initiated a recall of several orthopedic products, including 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. However, the packaging configuration used for these devices was only qualified for a five-year shelf life.
The recall involves 54,877 units across all affected products. The devices were distributed worldwide, including in the United States and various international locations such as Canada, the United Kingdom, and several European and Asian countries. The affected products include specific sizes of the Octane-C Cervical device, ranging from 5 mm to 12 mm, with all serial numbers for the listed catalog numbers affected.
Consumers and healthcare providers should check their inventory for these specific products and stop using them if they match the described labeling and catalog numbers. The FDA classifies this as a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
- 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.
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