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PedFuse Reset Screw Inserters recallZ-0555-2014 · SpineFrontier, Inc. · initiated Nov 20, 2013

Class II Terminated All recalls posted in December 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 SpineFrontier, 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

Screw inserters may not mate properly with hex interface of the screws.

FDA root cause category: Device Design

What the company is doing

The firm, SpineFrontier, Inc., sent an "Urgent PedFuse Screw Inserter Voluntary Recall Notification" letter on November 20, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to initiate the immediate return of the recalled products and to complete a recall ACKNOWLEDGEMENT FORM via fax or email to: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly MA 01915, Attn: Customer Service; Fax: 978-232-3991; email: [email protected]. Please feel free to contact at 978-232-3990 Monday thru Friday 8:30AM to 5:30PM Eastern with any questions.

Recall details

Recall number
Z-0555-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 20, 2013
Posted by the FDA
Dec 20, 2013
Recalling firm
SpineFrontier, Inc.
Quantity
13
Product code
MNI
FDA submissions
K123164
Distribution
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .

Product description

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

Code information (models, lots, serial numbers)

VM13222- 34489

Other devices under the same FDA submission

1 device cleared under K123164 — 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 66873).

Sources and updates

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