Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of bioBLOCK Resorbable Subtalar Implants because temperature indicators suggest exposure to temperatures greater than 110°F.
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 illnesses, injuries, or hospitalizations. The hazard is a potential loss of product integrity due to temperature exposure, which fits the criteria for a moderate severity recall involving a theoretical or unreported risk of harm.
Plain-English summary
Integra Limited is recalling 232 units of the Integra bioBLOCK Resorbable Subtalar Implant, 11mm (Catalog Number: 040011). The product is indicated for internal support to primary surgical interventions in the treatment of flatfoot. The recall involves Lot Numbers FGD2096 and FGD8328.
The recall was initiated because temperature indicators on the product may have changed color to dark gray or black prior to shipment. This color change indicates that the product may have been exposed to temperatures greater than 110°F. The affected units were distributed nationwide in the United States, specifically in the states of Ohio and Michigan.
Healthcare providers and patients should stop using the affected implants and contact Integra Limited for further instructions or a replacement. No specific instructions for patient action are provided in the source text beyond the recall notification.
The recalled product
- Product
- Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
- Manufacturer
- Integra Limited
- Affected units
- 232
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)
- Lot Numbers: FGD2096
- FGD8328
Distribution
Part of a larger recall action
This product is one of 3 recalled by Integra Limited 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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