Z-1156-2020 Class II Terminated
FDA device recall Z-1156-2020 was initiated by Medicrea International on October 2, 2019 and is designated Class II. Reason for recall: Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter The recall status is terminated (terminated February 8, 2021). Affected quantity: 14 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- October 2, 2019
- Termination Date
- February 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 units
Product Description
Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010
Reason for Recall
Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
Distribution Pattern
OH, VA
Code Information
Lot Numbers l9B0570; 19B0572