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.
- Company
- Stryker Spine
- Recall Initiated
- April 25, 2012
- Posted
- August 22, 2012
- Terminated
- February 27, 2013
- Recall Number
- Z-2235-2012
- Quantity
- 40 units.
- Firm Location
- Allendale, NJ
Reason for Recall
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.
Distribution
Distributed in Atlanta, Georgia.
Lot / Code Info
Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows: 48900445/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
Root Cause
Labeling mix-ups
Action Taken
Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was attached for customers to complete and return via fax to 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this notice.