• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall STRYKER SPINE TRIO SPINAL FIXATION SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
see related information
Date Posted April 10, 2009
Recall Status1 Terminated on April 14, 2009
Recall Number Z-0986-2009
Recall Event ID 50753
Premarket Notification
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, New Jersey 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = STRYKER SPINE
-
-