CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report
PedFuse Reset Screw Inserters recalled by SpineFrontier
SpineFrontier is recalling PedFuse Reset Screw Inserters, distributed in 7 states. The recall was initiated on 20 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0554-2014
- FDA event ID
- 66873
- Recalling firm
- SpineFrontier, Beverly, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Nov 2013
- FDA classified
- 20 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 20 Nov 2013 | Recall initiated by company | |
| 20 Dec 2013 | Classified by FDA | +30 days |
| 1 Jan 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Screw inserters may not mate properly with hex interface of the screws.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
Questions about this recall
Is PedFuse Reset Screw Inserters recalled?
Yes. SpineFrontier recalled PedFuse Reset Screw Inserters on 20 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0554-2014.
Why was it recalled?
Screw inserters may not mate properly with hex interface of the screws.
Which lots are affected?
VM 13194-34457
Where was it sold?
US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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