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Medtronic Sofamor Danek USA Inc Recall: KYPHON EXPRESS, Osteo Introducer System, Diamond a

Medtronic Sofamor Danek USA Inc Recall: KYPHON EXPRESS, Osteo Introducer System, Diamond a is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Sofamor Danek USA Inc; Product: KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE

Recalling firmMedtronic Sofamor Danek USA Inc
ProductKYPHON 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 recallThe 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionNationwide and Canada
Recall initiated20150113
Recall numberZ-1057-2015
Categorydevice
StateTN
CountryUnited States

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