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Terminated

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

FDA Recall Z-2091-2015 · Posted 2015-07-16

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHSB
Date Initiated2015-06-10
Date Terminated2016-08-18
Product Quantity32

Reason for Recall

The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

Firm Action

A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Official Source

View FDA Recall →

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

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