Exactech Recalls Shoulder and Spine Devices Due to Labeling Error
Exactech is recalling Equinoxe and Octane-C devices because labeling incorrectly states a ten-year shelf life for parts 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 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 was initiated because the firm determined that the device labeling identifies the affected parts as having a ten-year shelf life, while the packaging configuration used was 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 324-11-00, with a serial range of 1653706-2381151.
Healthcare providers and patients should check their inventory and medical records to determine if they possess or have received these specific devices. If the devices are found, they should be removed from service and returned to Exactech, Inc. according to the firm's instructions.
The recalled product
- Product
- Equinoxe Reverse Shoulder Fracture Adapter Tray 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 324-11-00 Serial Range 1653706-2381151
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.
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