V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Reported: October 19, 2016 Initiated: September 23, 2016 #Z-0069-2017
Product Description
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Reason for Recall
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Details
- Recalling Firm
- Cardinal Health 200, LLC
- Units Affected
- 72,076 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.. Recalled by Cardinal Health 200, LLC. Units affected: 72,076 units.
Why was this product recalled? ▼
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0069-2017.
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