Reported Aug 29, 2012 · Terminated
The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm…
Stryker Spine
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: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- The
- Instructions For Use for the followingStryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60
- mm STANDARD POST SCREW Manufactured bySTRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30
- http//www.stryker
- com Distributed in the USA byStryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine
- It is indicated fordegenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion
- Lot codes and dates
- Code information
- listed in the following formatManufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s
- are as follows48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201 48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197 48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198 48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599 48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
- Amount recalled
- 40 units.
Where it was sold
Why it was recalled
The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
This product could cause temporary or reversible health problems — stop using it.
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