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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 Device Recall Stryker Trio 3.5.MM Hex Socketsee related information
Date Initiated by FirmJuly 01, 2009
Date PostedSeptember 16, 2009
Recall Status1 Terminated 3 on October 20, 2009
Recall NumberZ-1886-2009
Recall Event ID 52658
510(K)NumberK032855 K052971 K062698 
Product Classification Hex Socket for Torque Wrench - Product Code MNH
ProductStryker 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 NJ 07401-1611
For Additional Information ContactTiffani 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
ActionProduct 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 Commerce143
DistributionNationwide - 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 CycleTPLC 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) Database510(K)s with Product Code = MNH
510(K)s with Product Code = MNH
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