FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- Recall number
- Z-1487-2018
- Recalling firm
- Integra LifeSciences Corp.
- Product
- TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- Status
- Terminated
- Initiated
- 2017-08-18
- Posted
- not on file
- Terminated
- 2018-07-19
- Reason
- 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
- Process control
- Action
- 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.
- Quantity
- 250
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- Lot 1216033
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ITG
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28