Recall Z-1941-2020
Medtronic Sofamor Danek USA Inc · initiated March 26, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Codes / lots: Product no. 6958838. UDI: 00613994354686.
Reason for recall
Nonconforming product; length of the product measured shorter than the labeled length.
FDA-determined cause: Nonconforming Material/Component
Action taken
Medtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form.
Details
- Recall number
- Z-1941-2020
- Initiated
- March 26, 2020
- Terminated
- March 26, 2021
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 83 units.
- Distribution
- US Nationwide distribution in the states of CA and MI.
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN