Reported Aug 13, 2014 · Terminated
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft…
X Spine Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X Spine Systems Inc · 452 Alexandersville Rd · Miamisburg, OH · 45342-3658
Is this the product you have?
- 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.
- Lot codes and dates
- Part numbers X079-0096 and X079-0097 with Lot #12320
- Amount recalled
- A total of 5-pieces of each part number distributed
Where it was sold
Why it was recalled
Revision B of the tissue shields of the device was 7 mm longer than the previous design.
This product could cause temporary or reversible health problems — stop using it.
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