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Synthes (USA) Products LLC recalls Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation
Recalled May 30, 2018 · FDA recall Z-1916-2018 · Synthes (USA) Products
Hazard
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. · FDA Class II
Units
50
Sold at
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.
Description
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.
Product
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →