Recall Z-0069-2017— Cardinal Health 200, LLC
Class II · Terminated
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2016-09-23, terminated 2019-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.. Reason: Potential risk associated with corrosion demonstrated on the distraction screw surface..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-23
- Terminated
- 2019-05-10
- Firm location
- Waukegan, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.