Synthes (USA) Products product recalled over labeling errors

Recall date

October 6, 2015

Source

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

Official notice title

Synthes (USA) Products LLC recalls 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended f…

Recall number

Z-0167-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Distribution to the state of : TN

Why it was recalled

Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.

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

What was recalled

2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.