Synthes (USA) Products LLC recalls Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set

Recall date

March 5, 2018

Source

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

Recall number

Z-2245-2018

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.

Why it was recalled

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

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

What was recalled

Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set