Z-2136-2014 Class II Terminated
FDA device recall Z-2136-2014 was initiated by X Spine Systems Inc on July 11, 2014 and is designated Class II. Reason for recall: Revision B of the tissue shields of the device was 7 mm longer than the previous design. The recall status is terminated (terminated August 14, 2014). Affected quantity: A total of 5-pieces of each part number distributed.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2014
- Initiation Date
- July 11, 2014
- Termination Date
- August 14, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A total of 5-pieces of each part number distributed
Product Description
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery.
Reason for Recall
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Distribution Pattern
US Distribution including the states of FL and MO.
Code Information
Part numbers X079-0096 and X079-0097 with Lot #12320