Recalls / —
—#162863
Product
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- FDA product code
- ITG — Bandage, Cast
- Device class
- Class 1
- Medical specialty
- Physical Medicine
- Affected lot / code info
- Lot 1216033
Why it was 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.
Root cause (FDA determination)
Process control
Action the firm took
On 8/18/17, the recalling firm's sales reps notified affected consignees of the recall and distributed customer letters. Customers were asked to examine their inventory for product from the affected lot, warned not to use the product, complete the included "Acknowledgement and Return Form", and return the form by email or fax. Customers were provided with a Customer Service number: 1-800-654-2873.
Recalling firm
- Firm
- Integra LifeSciences Corp.
- Address
- 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344
Distribution
- Distribution pattern
- US nationwide distribution.
Timeline
- Recall initiated
- 2017-08-18
- Terminated
- 2018-07-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.