Z-0546-2020 Class III Terminated
FDA device recall Z-0546-2020 was initiated by SPINEART SA on February 5, 2019 and is designated Class III. Reason for recall: Inner blister pack label is incorrect and does not match the correct external box label. The recall status is terminated (terminated April 28, 2021). Affected quantity: 14 pieces distribtued to 1 US Distributor.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- February 5, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 pieces distribtued to 1 US Distributor
Product Description
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
Reason for Recall
Inner blister pack label is incorrect and does not match the correct external box label.
Distribution Pattern
US: CA OUS: Unknowns
Code Information
Model Number: JUT-OX 28 09-S Lot Number: 4-2899 UDI: (01) 0 7640178 97398 5 (11) 181102 (17) 261101 (10) 4-2899