KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with
FDA device recall Z-1057-2015 · posted 2015-02-05 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LYQ
- Quantity affected
- 239 units
- Distribution
- Nationwide and Canada
- Date initiated
- 2015-01-13
- Date posted
- 2015-02-05
- Date terminated
- 2015-07-13
- Location
- Memphis, TN
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