TCC-EZ recall
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Why was TCC-EZ recalled?
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 1216033
- Product
- TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 250
- Distribution
- US nationwide distribution.
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)