Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error
Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.
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 voluntary precautionary recalls without reported injuries.
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, whereas the packaging configuration used was only qualified to a five-year shelf life.
The recall involves 54,877 units distributed worldwide, including the United States and international locations such as Austria, Luxembourg, Sweden, Germany, Spain, France, Greece, Italy, the Netherlands, the United Kingdom, Canada, India, Australia, Switzerland, and São Paulo. The affected products are intended for primary and reverse total shoulder arthroplasty.
Consumers and healthcare providers should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Equinoxe Fixed Angle Replicator Plate 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)
- Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151
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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