Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Serrated Soft Tissue Shields. Orthopedic surgical instruments Recalled by X Spine Systems Inc Due to Revision B of the tissue shields of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact X Spine Systems Inc directly.
Affected Products
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.
Quantity: A total of 5-pieces of each part number distributed
Why Was This Recalled?
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Where Was This Sold?
This product was distributed to 2 states: FL, MO
About X Spine Systems Inc
X Spine Systems Inc has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report