PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 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.
This recall has been terminated (originally issued December 20, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- November 20, 2013
- Posted
- December 20, 2013
- Terminated
- June 26, 2018
- Recall Number
- Z-0554-2014
- Quantity
- 25
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Screw inserters may not mate properly with hex interface of the screws.
Distribution
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Lot / Code Info
VM 13194-34457
Root Cause
Device Design
Action Taken
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: customerservice@spinefrontier.com. Please feel free to contact at 978-232-3990 Monday thru Friday 8:30AM to 5:30PM Eastern with any questions.