Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure
Exactech is recalling two units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to a cold storage equipment failure.
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 the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential deviation from storage conditions without confirmed adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
Exactech, Inc. is recalling two units of the Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30. The recall was initiated because the devices were potentially exposed to higher temperatures than those documented in the Instructions for Use (IFU) due to a failure of the cold storage equipment.
The affected units are identified by UDI 10885862093202 and Serial Numbers T31634510 and T31788559. The distribution pattern for these units includes Oklahoma, Virginia, and Florida.
Healthcare providers and facilities should check their inventory for these specific serial numbers and stop using the affected devices. They should contact Exactech, Inc. for further instructions on how to return or dispose of the recalled units.
The recalled product
- Product
- Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
- Manufacturer
- Exactech, Inc.
- Affected units
- 2
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)
- UDI 10885862093202 Serial Numbers: T31634510
- T31788559
Distribution
Part of a larger recall action
This product is one of 3 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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