Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Instructions For Use for the following: Stryker TRIO+ 4.5 Recalled by Stryker Spine Due to The front cover of Instructions For Use (IFU)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Spine directly.
Affected Products
The Instructions For Use for the following: Stryker 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 by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker 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 for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
Quantity: 40 units.
Why Was This 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.
Where Was This Sold?
Distributed in Atlanta, Georgia.
About Stryker Spine
Stryker Spine has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report