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X Spine Systems Inc recalls Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tis
Recalled August 13, 2014 · FDA recall Z-2136-2014 · X Spine Systems
Hazard
Revision B of the tissue shields of the device was 7 mm longer than the previous design. · FDA Class II
Units
A total of 5-pieces of each part number distributed
Sold at
US Distribution including the states of FL and MO.
Description
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
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.
Manufacturer(s)
X Spine Systems Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →