Reported Apr 29, 2015 · Terminated
Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods,…
X Spine Systems 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: X Spine Systems Inc · 452 Alexandersville Rd · Miamisburg, OH · 45342-3658
Is this the product you have?
- Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.
- Lot codes and dates
Lot #: 4084-01M/N X073-5555
- UDI*+M697X07355551/$408401U*
- Amount recalled
- 14 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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