Synthes (USA) Products LLC recalls DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43

Recall date

May 2, 2016

Source

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

Recall number

Z-1912-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US nationwide distribution.

Why it was recalled

Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.

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

What was recalled

DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43