Z-1941-2020 Class II Terminated
FDA device recall Z-1941-2020 was initiated by Medtronic Sofamor Danek USA Inc on March 26, 2020 and is designated Class II. Reason for recall: Nonconforming product; length of the product measured shorter than the labeled length. The recall status is terminated (terminated March 26, 2021). Affected quantity: 83 units..
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- March 26, 2020
- Termination Date
- March 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 units.
Product Description
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Reason for Recall
Nonconforming product; length of the product measured shorter than the labeled length.
Distribution Pattern
US Nationwide distribution in the states of CA and MI.
Code Information
Product no. 6958838. UDI: 00613994354686.