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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Trio 3.5.MM Hex Socket

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 Class 2 Recall
Stryker Trio 3.5.MM Hex Socket
see related information
Date Posted September 16, 2009
Recall Status1 Terminated on October 20, 2009
Recall Number Z-1886-2009
Recall Event ID 52658
Premarket Notification
510(K) Numbers
K032855  K052971  K062698 
Product Classification Orthosis, Spondylolisthesis Spinal Fixation - Product Code MNH
Product Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the USA by: Stryker Spine, Allendale, NJ 07401 The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Socket is used with the Trio implant system for posterior noncervical pedical and non pedical fixation of the spine.
Code Information Catalog number 48906075, all lots
Recalling Firm/
Manufacturer
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611
For Additional Information Contact Tiffani Rogers
201-760-8206
Manufacturer Reason
for Recall
The Trio 3.5MM Hex socket has been reported to break under high stresses.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Product Correction letters were sent on July 1, 2009 to all Branches/Agencies, Surgeons and Hospital Risk Management OR Supervisor by Federal Express. The letter indicates the potential hazards associated with the breakage and it reinforces the appropriate surgical technique in using the hex socket. Customers are requested to complete an acknowledgement form and return it via FAX to Aminah Crawford at 201.760.8370 within five (5) days of receipt of the notice. If you have questions, please contact Tiffani Rogers, Regulatory Compliance Manager at 201.760.8206.
Quantity in Commerce 143
Distribution Nationwide - OR, AR, CA, MA, KY, MD, GA, FL, NY, NM, UT, FL, OK, KS, MI, MN, IN, MT, TX, WI, 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 = MNH and Original Applicant = HOWMEDICA OSTEONICS
510(K)s with Product Code = MNH and Original Applicant = STRYKER SPINE
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