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.
FDA Recall Z-0555-2014 · Posted 2013-12-20
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Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2013-11-20
Date Terminated2018-06-26
Product Quantity13
Reason for Recall
Screw inserters may not mate properly with hex interface of the screws.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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