Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2136-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-07-11 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2136-2014
Date of alert
2014-07-11
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
X Spine Systems Inc
Product category
device
Product type
Devices
Reported risk: Revision B of the tissue shields of the device was 7 mm longer than the previous design.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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