Devices

Device Recall Serrated Soft Tissue Shields

Model / Serial
Part numbers X079-0096 and X079-0097 with Lot #12320
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
US Distribution including the states of FL and MO.
Product Description
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
X Spine Systems Inc
1 Event
- Recall of Device Recall Serrated Soft Tissue Shields

Manufacturer

X Spine Systems Inc

Manufacturer Address
X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
Manufacturer Parent Company (2017)
X-Spine Systems, Inc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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