Reported Jul 1, 2015 · Terminated
Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road…
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?
- Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg
- OH 45342 Phone937-847-8400
- Lot codes and dates
Model #: N60001068Lot #: 2943-01Serial #s: 461184658147296475884765348164482014841249156495854958649649G22G45G47G77G83G87XG90XR15XP03XP21XP27XP28XP29 & XP32
- Amount recalled
- 75 units
Where it was sold
Why it was recalled
The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.
This product could cause temporary or reversible health problems — stop using it.
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