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Terminated

lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

FDA Recall Z-0977-2015 · Posted 2015-01-14

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2014-12-19
Date Terminated2016-01-11
Product Quantity4 devices

Reason for Recall

A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.

Firm Action

Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution including TX, OH, VA, and Washington, DC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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