Synthes (USA) Products LLC recalls Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

Recall date

May 4, 2018

Source

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

Recall number

Z-1916-2018

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.

Why it was recalled

The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.

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 Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.