Recall Z-2136-2014— X Spine Systems Inc
Class II · Terminated
Class II FDA medical device recall by X Spine Systems Inc, initiated 2014-07-11, terminated 2014-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Revision B of the tissue shields of the device was 7 mm longer than the previous design..
- Recalling firm
- X Spine Systems Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-11
- Terminated
- 2014-08-14
- Firm location
- Miamisburg, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.