Synthes (USA) Products LLC recalls Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head…

Recall date

June 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2091-2015

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Nationwide Distribution.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.