—#133557

Product

KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.

FDA product code: LYQ — Accessories, Fixation, Spinal Intervertebral Body
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: WI14H054

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

On January 12, 2015, the Sales Managers and Sales Force were notified by Post-Market Quality regarding the imminent notification and follow-up activities. The recall notices were delivered to the Risk Managers at impacted consignee sites on January 13, 2015. These recall notices included a Risk Manager Letter informing them on the action, and a consignee-specific questionnaire to indicate their product on-hand.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2015-01-13
Posted by FDA: 2015-02-05
Terminated: 2015-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133557. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.