Recall Z-1878-2017— Ulrich Medical USA Inc
Class II · Terminated
Class II FDA medical device recall by Ulrich Medical USA Inc, initiated 2017-03-07, terminated 2017-11-30. It names one FDA 510(k) clearance: K150666. Product: 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.. Reason: Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating..
- Recalling firm
- Ulrich Medical USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-07
- Terminated
- 2017-11-30
- Firm location
- Chesterfield, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.