6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Reported: November 28, 2012 Initiated: January 5, 2009 #Z-0360-2013
Product Description
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Reason for Recall
The tulip portion of the screw assembly can disengage from the shank after implantation.
Details
- Recalling Firm
- NuVasive Inc
- Units Affected
- 240 units total
- Distribution
- Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI. Recalled by NuVasive Inc. Units affected: 240 units total.
Why was this product recalled? ▼
The tulip portion of the screw assembly can disengage from the shank after implantation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0360-2013.
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