RecallRadar

FDA Device recall Z-0781-2013

Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjus…

On 2013-02-13 the FDA classified a Class II recall of Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjus… by Synthes Usa Hq, citing although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0781-2013
ClassificationClass II
Statusterminated
Initiated2012-08-06
Published2013-02-13
Last updated2026-09-13 11:53 UTC
CompanySynthes Usa Hq
DistributionUS

Product

Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7).

Reason

Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

Identifiers

code_info2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0781-2013%22

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