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Terminated

Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).

FDA Recall Z-0475-2016 · Posted 2015-12-23

Recalling FirmArthrosurface, Inc.
Recall StatusTerminated
Product CodeLZJ
Date Initiated2014-06-09
Date Terminated2016-02-05
Product Quantity3 units

Reason for Recall

An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

Firm Action

The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.

Root Cause

Process change control

Distribution Pattern

US Distribution to the states of : PA, WV and CA.

Official Source

View FDA Recall →

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

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