← RecallGuard
HomeRecalls

X Spine Systems Inc Recall: Serrated Soft Tissue Shields. Orthopedic surgical instruments,

X Spine Systems Inc Recall: Serrated Soft Tissue Shields. Orthopedic surgical instruments, is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: X Spine Systems Inc; Product: Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft t

Recalling firmX Spine Systems Inc
ProductSerrated 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 recallRevision B of the tissue shields of the device was 7 mm longer than the previous design.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionUS Distribution including the states of FL and MO.
Recall initiated20140711
Recall numberZ-2136-2014
Categorydevice
StateOH
CountryUnited States

🔍 Search all recalls →