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U.S. Department of Health and Human Services

Class 2 Device Recall System 26 Headed and Headless Bone Screw and Washer System

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 Class 2 Device Recall System 26 Headed and Headless Bone Screw and Washer Systemsee related information
Date Initiated by FirmOctober 10, 2017
Create DateMarch 09, 2018
Recall Status1 Terminated 3 on August 31, 2018
Recall NumberZ-0967-2018
Recall Event ID 79218
510(K)NumberK163489 
Product Classification Screw, fixation, bone - Product Code HWC
ProductSYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS; OS900055-NS; OS900056-NS; OS900058-NS; OS900059-NS; OS900057-NS.
Code Information Lot Numbers: 1088402;1088403;1088404;1088405;1088406;1091608;1091646; 1091648;1091628;1088393;1091658; 1088394;1091586; 1088395;1091598;1088396;1088397;1091623; 1088398;1091618; 1088399;1091596; 1091599; 1088401;1091597; 1088337;1091622;1093232;1088985;1091542; 1088986;1091401;1088987;1091581;1091543; 1088989;1091589;1088990;1091614; 1088991;1091402;1091562
FEI Number 3008951116
Recalling Firm/
Manufacturer		 ORTHO SOLUTIONS, LTD.
West Station Business Park
Spital Road
Maldon United Kingdom
Manufacturer Reason
for Recall		Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
FDA Determined
Cause 2		Process control
ActionOrtho Solutions notified customers of the recall via letter 10/10/2017. The recall notification letter was accompanied by instructions to Distributors and a Product Removal Form.
Quantity in Commerce120
DistributionU.S.
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 = HWC
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