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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MNI
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