Leucadia Autolok" Polyaxial Pedicle Screw System. recall
Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Why was Leucadia Autolok" Polyaxial Pedicle Screw System. 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
83010 85001 85002 83005-30 83005-35 83005-40 83005-45 83005-50 83006-30 83006-35 83006-40 83006-45 83006-50 83006-55 83006-60 83007-30 83007-35 83007-40 83007-45 83007-50 83007-55 83008-30 83008-35 83008-40 83008-45 83008-50 83008-55 83008-80 82001-1 Catalog Numbers: LA-HSS0010 LA-HDOO01 LA-CTOO02 LA-PS0530 LA-PS0535 LA-PS0540 LA-PS0545 LA-PS0550 LA-PS0630 LA-PS0635 LA-PS0640 LA-PS0645 LA-PS0650 LA-PS0655 LA-PS0660 LA-PS0730 LA-PS0735 LA-PS0740 LA-PS0745 LA-PS0750 LA-PS0755 LA-PS0830 LA-PS0835 LA-PS0840 LA-PS0845 LA-PS0850 LA-PS0855 LA-PS0880 LA-SOO01 Lots Affected: All
- Product
- Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
- Recalling firm
- Alphatec Spine, Inc.
- Quantity
- 1,814
- Distribution
- Nationwide Distribution.
- Recall date
- June 5, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)