Exactech Recalls Opteform Allograft Discs Due to Cold Storage Failure
Exactech, Inc. 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.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Exactech, Inc. is recalling two units of the Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45. The recall was initiated because the products 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 10885862093219 and Serial Numbers T32309666 and T32309672. The distribution pattern for these units includes Oklahoma, Virginia, and Florida. The source text notes that the Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to these conditions.
Healthcare providers and facilities should check their inventory for the specific serial numbers listed and contact Exactech, Inc. for further instructions regarding the return or disposal of these units.
The recalled product
- Product
- Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
- Manufacturer
- Exactech, Inc.
- Category
- Medical Device — Allograft
- Hazard
- 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 10885862093219 Serial Numbers: T32309666
- T32309672
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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