FDAFDA · Food and drugs·Recall number 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.
Published August 13, 2014 · Recall initiated: July 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- X Spine Systems Inc
- Distributor
- US Distribution including the states of FL and MO.
- Lot
- Part numbers X079-0096 and X079-0097 with Lot #12320
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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