FDAClass IIFebruary 13, 2013

Synthes(R) Spine Vectra recall

Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes…

Why was Synthes(R) Spine Vectra recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939

Product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes…
Recalling firm
Synthes USA HQ, Inc.
Quantity
48
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, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
Recall date
February 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls