Class 2 Device Recall STRYKER SPINE TRIO SPINAL FIXATION SYSTEM

• Date Initiated by Firm: September 05, 2006
• Date Posted: April 10, 2009
• Recall Status: Terminated on April 14, 2009
• Recall Number: Z-0986-2009
• Recall Event ID: 50753
• 510(K)Number: K052971
• Product Classification: Orthosis, spinal pedicle fixation - Product Code MNI
• Product: Stryker Trio Small Offset Connector Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ. The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion.
• Code Information: Catalog Number 48902015; Lot codes: 056254, 056255, 056256, 056257, 56258, 056259, 058065, 05A140, 05A142, 058066, 05A139, 05A141, 058915, 05A143, 05A145, 05A146, 05A144, 061075, 061077, 061551, 061072, 061076, 0615550, 061549, 061760, 05A148, 05A149, and 05A147.
• Recalling Firm/ Manufacturer: Stryker Spine; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Michelle Klein; 201-760-8256
• Manufacturer Reason for Recall: Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
• FDA Determined Cause: Device Design
• Action: A notification letter dated September 12, 2006 and a Product Accountability Form were sent via Federal Express (with return receipt) to all affected branches/agencies. Further information can be found by calling 1-201-760-8256.
• Quantity in Commerce: 2,417 units
• Distribution: Nationwide Distribution including OR, CA, MA, VA, GA, FL, NY, NM, NJ, UT, KS, OH, MI, MN, IN, MT, TX, WI, AL, CO, and TN.
• 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