FDA-Device2020-03-04Class II
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
ulrich medical USA Inc
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.
Sold states
AZ, TX, GA, FL, AR, CA
Affected count
179 units
Manufactured in
18221 Edison Ave, N/A, Chesterfield, MO, United States
Products
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2020Don't want to check this manually?
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