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Terminated

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 Recall Z-1057-2015 · Posted 2015-02-05

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeLYQ
Date Initiated2015-01-13
Date Terminated2015-07-13
Product Quantity239 units

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Nationwide and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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