Exactech Recalls Tibial Alignment Guides Due to Incorrect GTIN Labeling
Exactech is recalling 7 Tibial Alignment Guides because the Global Trade Item Number (GTIN) printed on the devices is incorrect.
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 due to a minor labeling error (incorrect GTIN) that does not pose a direct risk of serious injury or death, fitting the criteria for moderate severity.
Plain-English summary
Exactech, Inc. is recalling 7 units of the Tibial Alignment Guide (REF 351-10-00), which are components of the Vantage Fixed Ankle system used for ankle replacements. The recall was initiated because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN currently reads 10885862525629, but it should read 10885862525628.
The affected units were distributed to locations in California, Ohio, New York, Oklahoma, Florida, Texas, South Carolina, Germany, Spain, Switzerland, and the United Kingdom. The specific lot number for the recalled items is 098299003.
This recall is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for Tibial Alignment Guides with the incorrect GTIN and contact Exactech for instructions on how to proceed.
The recalled product
- Product
- Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 7
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 (2)
- GTIN10885862525629
- Lot Number 098299003
Distribution
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