Recall Z-1750-2018— Medtronic Sofamor Danek USA Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2018-03-23, terminated 2021-07-25. It names one FDA 510(k) clearance: K141632. Product: Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body. Reason: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-23
- Terminated
- 2021-07-25
- Firm location
- Memphis, TN, 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
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
Reason for recall
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Data sourced from openFDA. This site is unofficial and independent of the FDA.