Integra LifeSciences Recalls TCC-EZ Total Contact Cast System
Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (excessive heat output) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Integra LifeSciences Corp. is recalling 250 units of the TCC-EZ Total Contact Cast System, Model No. TCC2-4051. The recall affects Lot 1216033, which was distributed nationwide in the United States.
The recall was initiated because a quarantined lot of the devices was released for sale. Devices from this lot may experience an increased exothermic reaction, causing higher levels of heat output that exceed the product specifications.
Consumers who have this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 250
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 1216033
Distribution
Distributed nationwide across the United States.
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