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Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior… recallZ-0782-2013 · Synthes USA HQ, Inc. · initiated Aug 6, 2012

Class II Terminated All recalls posted in February 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Component design/selection

What the company is doing

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.

Recall details

Recall number
Z-0782-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 6, 2012
Posted by the FDA
Feb 4, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
48
Product code
KWQ
FDA submissions
K050451, K051665, K071667
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.

Product description

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

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

13 devices cleared under K050451, K051665, K071667 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 62943).

Sources and updates

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