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Terminated

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

FDA Recall Z-1487-2018 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeITG
Date Initiated2017-08-18
Date Terminated2018-07-19
Product Quantity250

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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