PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
FDA Recall Z-0544-2014 · Posted 2013-12-19
Advertisement
Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2013-10-18
Date Terminated2016-08-22
Product Quantity35 Devices
Reason for Recall
During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have
consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity.
Firm Action
SpineFrontier sent an Voluntary Recall Notification dated November 5,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers.
All affected implants are to be returned to SpineFrontier for inspection. SpineFrontier is requiring confirmation that you have received this notice and that you will initiate the immediate return of the implants listed above.
IMMEDIATE RESPONSE REQUIRED.
Please feel free to contact us at 978-232-3990 Monday through Friday
8:30AM to 5:30PM EST with any questions
Root Cause
Software design (manufacturing process)
Distribution Pattern
US Distribution to VA and TX.
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.
Advertisement