Synthes 0 recalled over sterility concerns

Recall date

November 1, 2016

Source

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

Official notice title

Synthes (USA) Products LLC recalls Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

Recall number

Z-0681-2017

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Distributed Nationwide

Why it was recalled

Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

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

What was recalled

Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile