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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
Date Initiated by Firm May 15, 2006
Date Posted June 17, 2006
Recall Status1 Terminated 3 on July 04, 2006
Recall Number Z-1155-06
Recall Event ID 35536
Product Classification Mobile Surgery Platform - Product Code FSE
Product Stryker Trio Mobile Surgery Platform; Model 1033.
Code Information Serial numbers 0412060619, 0501073240, 0501073241, 0501073327, 0501073328, 0501073329, 0501073330, 0408062292, 0408062293, 0502069215, 0504072232, 0409062008, 0409062003, 0409062004, 0409062005, 0409062006, 0410065050, 0502069214, 0410058767, 0409062001, 0409062274, 0512070516, 0602079782, 0602079817, 0602079818, 0602079819, 0408062389, 0408062390, 0408062391, 0409062007, 0411060535, 0506071242, 0410065046, 0501073064, 0501073065, 0501073066, 0501073084, 0501073085, 0501073086, 0501073087, 0501073188, 0501073189, 0501073190, 0602079542, 0506071118, 0510071070, 0510071071, 0510071072, 0605087579, 0504072089, 0602079541, 0505069588, 0502069314, 0502069315, 0510071241, 0511071674, 0511071675, 0511071676, 0511071677, 0511071678, 0511071679, 0511071680, 0504072088, 0512070514, 0512070515, 0412060744, 0412060745, 0412060746, 0412060855, 0412060856, 0412060857, 0501073001, 0501073002, 0501073003, 0502069148, 0601084043, 0507070537, 0510071069, 0502069034, 0502069035, 0502069036, 0502069150, 0502069151, 0502069152, 0502069153, 0510071243, 0410058765, 0507070691, 0507070692, 0507070693, 0507070694, 0507070695, 0507070696, 0507070697, 0507070698, 0507070699, 0507070700, 0603084573, 0409062002, 0410058766, 0502069149, 0503068501, 0503068502, 0503068503, 0506071116, 0506071117, 0506071241, 0603084574, 0410065049, 0501073373, 0501073374, 0501073375, 0501073376, 0502069032, 0502069033, 0502069313, 0603084672, 0411060618, 0411060619, 0411060620, 0411060621, 0411060802, 0411060803, 0411060804, 0412060504, 0412060505, 0412060506, 0412060616, 0412060617, 0412060618, 0505069589, 0505069590, 0505069591, 0505069592, 0410065047, 0509069501, 0509069502, 0505069749, 0505069750, 0502069216,  0410065045, 0410065048, 0411060801, 0408062151, 0409062273, 0409062275, 0502069312, 0503068633, 0503068634, 0503068635, 0503068636, 0511071540, 0511071541, 0511071542, 0511071543 and 0503068637. 
Recalling Firm/
Manufacturer		 Stryker Medical Div. of Stryker Corporation
3800 E. Centre Ave.
Portage MI 49002
For Additional Information Contact
800-669-4968 Ext. 6689
Manufacturer Reason
for Recall		 An incorrect pin may have been used during assembly and therefore the device may give way during use.
FDA Determined
Cause 2		 Other
Action Consignees were called on 5/15/06 and instructed to discontinue use of these devices until the firm's technician has visited the facility and replaced the pin.
Quantity in Commerce 156
Distribution Worldwide (including USA, Australia, Canada, England, Germany, Italy, Romania and Singapore).
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.
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