Ulrich Medical USA Recalls

Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

Class I - Dangerous

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.

Dec 31, 2019 Other Medical Devices View Details →

ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.

Class I - Dangerous

Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.

Mar 8, 2019 Implants & Prosthetics View Details →

uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

Class I - Dangerous

Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.

Mar 7, 2017 Infusion Pumps Nationwide View Details →