Reported Jun 5, 2013 · Terminated
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization…
Alphatec Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alphatec Spine, Inc. · 5818 El Camino Real · Carlsbad, CA · 92008-8816
Is this the product you have?
- Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
- Lot codes and dates
83010850018500283005-3083005-3583005-4083005-4583005-5083006-3083006-3583006-4083006-4583006-5083006-5583006-6083007-3083007-3583007-4083007-4583007-5083007-5583008-3083008-3583008-4083008-4583008-5083008-5583008-8082001-1
- Catalog Numbers
LA-HSS0010LA-HDOO01LA-CTOO02LA-PS0530LA-PS0535LA-PS0540LA-PS0545LA-PS0550LA-PS0630LA-PS0635LA-PS0640LA-PS0645LA-PS0650LA-PS0655LA-PS0660LA-PS0730LA-PS0735LA-PS0740LA-PS0745LA-PS0750LA-PS0755LA-PS0830LA-PS0835LA-PS0840LA-PS0845LA-PS0850LA-PS0855
- LA-PS0880 LA-SOO01 Lots AffectedAll
- Amount recalled
- 1,814
Where it was sold
- Nationwide
Why it was recalled
Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing, the flange of the Phygen Leucadia" Autolok set screw may interfere with the top of the screw head prior to fully locking the rod. If this condition occurs, the polyaxial screw head and rod may fail to provide a rigid construct under loading. To date there have been no reports of patient injury, adve
This product could cause temporary or reversible health problems — stop using it.
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