Integra bioBLOCK Resorbable Subtalar Implant Recalled for Temperature Exposure
Integra Limited is recalling 232 units of the bioBLOCK Resorbable Subtalar Implant because temperature indicators suggest exposure to temperatures above 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a potential temperature excursion that may compromise product integrity, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integra Limited is recalling 232 units of the Integra bioBLOCK Resorbable Subtalar Implant, 12mm (Catalog Number: 040012, Lot Number: FGD8329). The product is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
The recall was initiated because the temperature indicator 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. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot.
- Manufacturer
- Integra Limited
- Hazard
- 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 (1)
- Lot Number: FGD8329
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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