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ulrich medical USA Inc recalls Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Recalled March 4, 2020 · FDA recall Z-1350-2020 · ulrich medical USA
Hazard
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. · FDA Class II
Units
179 units
Sold at
AZ, TX, GA, FL, AR, CA
Description
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Product
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Manufacturer(s)
ulrich medical USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →