Z-1487-2018Class II

TCC-EZ, Total Contact Cast System, Model No. TCC2-4051

Name: Z-1487-2018 TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Creator: Integra LifeSciences Corp.
Published: 2017-08-18
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2017-08-18 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 on 2017-08-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1487-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-18
Posted: 2018-04-24
Terminated: 2018-07-19
Recalling firm: Integra LifeSciences Corporation
Product: TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Product code: ITG Bandage, Cast
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 250
Distribution: US nationwide distribution.
Product codes and lots: Lot 1216033

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1487-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1487-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24

Product code ITG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)