Xpress System Pedicle Screw Assembly recall
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw…
Why was Xpress System Pedicle Screw Assembly recalled?
One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.
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?
Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*
- Product
- Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw…
- Recalling firm
- X Spine Systems Inc
- Quantity
- 14 units
- Distribution
- US Distribution to states of: KS, NV & TX.
- Recall date
- April 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)