Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduate

FDA device recall Z-0781-2013 · posted 2013-02-04 · Terminated

Recall details

Recalling firm: Synthes USA HQ, Inc.
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.
Action taken: Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated August 6, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 610-719-5450 for questions related to this notice.
Root cause: Component design/selection
Status: Terminated
Product code: KWQ
Quantity affected: 63
Distribution: Nationwide Distribution-including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV,
Date initiated: 2012-08-06
Date posted: 2013-02-04
Date terminated: 2015-08-31
Location: West Chester, PA

Recalls and clearances share one API, with change alerts when new recalls post.