Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure
Exactech is recalling three units of Opteform Allograft Discs because they were potentially exposed to higher temperatures than documented due to 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, but 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 three units of the Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90. The recall involves specific serial numbers T31977961, T31977962, and T31977968, associated with UDI 10885862094100.
The recall was initiated because the Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the Instructions for Use (IFU). This exposure occurred due to a failure of the cold storage equipment.
The affected units were distributed to Oklahoma, Virginia, and Florida. Healthcare providers and patients should check their inventory and records for these specific serial numbers. If the product is found, it should be removed from use and returned to Exactech, Inc. in accordance with the recall instructions.
The recalled product
- Product
- Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
- Manufacturer
- Exactech, Inc.
- Affected units
- 3
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 (3)
- UDI 10885862094100 Serial Numbers: T31977961
- T31977962
- T31977968
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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