FDAFDA · Food and drugs·Recall number Z-0544-2014
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.
Published December 25, 2013 · Recall initiated: October 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US Distribution to VA and TX.
- Lot
- Lot/Serial Numbers: 357305-000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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