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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker TRIO/TRIO

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  Class 2 Device Recall Stryker TRIO/TRIO see related information
Date Initiated by Firm April 25, 2012
Date Posted August 22, 2012
Recall Status1 Terminated 3 on February 27, 2013
Recall Number Z-2235-2012
Recall Event ID 62663
510(K)Number K062698  
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
Product 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.
Code Information 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            
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action 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.
Quantity in Commerce 40 units.
Distribution Distributed in Atlanta, Georgia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = STRYKER SPINE
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