KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Reported: February 11, 2015 Initiated: January 13, 2015 #Z-1057-2015
Product Description
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
Reason for Recall
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 239 units
- Distribution
- Nationwide and Canada
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 239 units.
Why was this product recalled? ▼
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2015. Severity: Moderate. Recall number: Z-1057-2015.
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