Recall Z-0781-2013— Synthes USA HQ, Inc.

Name: FDA recall Z-0781-2013
Creator: U.S. Food and Drug Administration
Published: 2012-08-06

Class II · Terminated

Class II FDA medical device recall by Synthes USA HQ, Inc., initiated 2012-08-06, terminated 2015-08-31. It names 3 FDA 510(k) clearances: K071667, K051665, K050451. 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..

Recalling firm: Synthes USA HQ, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-08-06
Terminated: 2015-08-31
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

3 on FDA's record

K071667 — SYNTHES VECTRA-ONE SYSTEMSynthes Spine·cleared 2007-11-30
K051665 — SYNTHES VECTRA-T SYSTEMSynthes Spine·cleared 2005-09-09
K050451 — SYNTHES VECTRA SYSTEMSynthes Spine Co.Lp·cleared 2005-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.