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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmAugust 12, 2005
Date PostedOctober 15, 2005
Recall Status1 Terminated 3 on July 20, 2006
Recall NumberZ-0060-06
Recall Event ID 33196
510(K)NumberK032898 
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
ProductT2 Recon Nail System.
Code Information Catalog No./Description/Lot Code:  18976065S-- T2 Recon Lag Screw 6.5x65MM--K454322; T2 Recon Lag Screw 6.5x65MM--K518614; T2 Recon Lag Screw 6.5x65MM--K518615; T2 Recon Lag Screw 6.5x65MM--K518616; T2 Recon Lag Screw 6.5x65MM--K518617; T2 Recon Lag Screw 6.5x65MM--K678251; T2 Recon Lag Screw 6.5x65MM--K678252.  18976070S-- T2 Recon Lag Screw 6.5x70MM--K412886; T2 Recon Lag Screw 6.5x70MM--K412887; T2 Recon Lag Screw 6.5x70MM--K454324; T2 Recon Lag Screw 6.5x70MM--K497821; T2 Recon Lag Screw 6.5x70MM--K518728; T2 Recon Lag Screw 6.5x70MM--K678253; T2 Recon Lag Screw 6.5x70MM--K678254.  18976075S-- T2 Recon Lag Screw 6.5x75MM--K400117; T2 Recon Lag Screw 6.5x75MM--K454326; T2 Recon Lag Screw 6.5x75MM--K518854; T2 Recon Lag Screw 6.5x75MM--K518855; T2 Recon Lag Screw 6.5x75MM--K518857; T2 Recon Lag Screw 6.5x75MM--K518858; T2 Recon Lag Screw 6.5x75MM--K678255; T2 Recon Lag Screw 6.5x75MM--K678256.  18976080S-- T2 Recon Lag Screw 6.5x80MM--K400118; T2 Recon Lag Screw 6.5x80MM--K454327; T2 Recon Lag Screw 6.5x80MM--K519005; T2 Recon Lag Screw 6.5x80MM--K519008; T2 Recon Lag Screw 6.5x80MM--K519009; T2 Recon Lag Screw 6.5x80MM--K678257; T2 Recon Lag Screw 6.5x80MM--K678258.  18976085S-- T2 Recon Lag Screw 6.5x85MM--K400119; T2 Recon Lag Screw 6.5x85MM--K412895; T2 Recon Lag Screw 6.5x85MM--K454328; T2 Recon Lag Screw 6.5x85MM--K488715; T2 Recon Lag Screw 6.5x85MM--K519003; T2 Recon Lag Screw 6.5x85MM--K519176; T2 Recon Lag Screw 6.5x85MM--K519177; T2 Recon Lag Screw 6.5x85MM--K519178; T2 Recon Lag Screw 6.5x85MM--K519182; T2 Recon Lag Screw 6.5x85MM--K519183; T2 Recon Lag Screw 6.5x85MM--K519184; T2 Recon Lag Screw 6.5x85MM--K519185; T2 Recon Lag Screw 6.5x85MM--K519186; T2 Recon Lag Screw 6.5x85MM--K678259; T2 Recon Lag Screw 6.5x85MM--K678260; T2 Recon Lag Screw 6.5x85MM--K757952.  18976090S-- T2 Recon Lag Screw 6.5x90MM--K400120; T2 Recon Lag Screw 6.5x90MM--K454329; T2 Recon Lag Screw 6.5x90MM--K488717; T2 Recon Lag Screw 6.5x90MM--K519286; T2 Recon Lag Screw 6.5x90MM--K519288; T2 Recon Lag Screw 6.5x90MM--K519289; T2 Recon Lag Screw 6.5x90MM--K519290; T2 Recon Lag Screw 6.5x90MM--K519291; T2 Recon Lag Screw 6.5x90MM--K519292; T2 Recon Lag Screw 6.5x90MM--K519293; T2 Recon Lag Screw 6.5x90MM--K678262; T2 Recon Lag Screw 6.5x90MM--K757953.  18976095S-- T2 Recon Lag Screw 6.5x95MM--K400121; T2 Recon Lag Screw 6.5x95MM--K412911; T2 Recon Lag Screw 6.5x95MM--K412914; T2 Recon Lag Screw 6.5x95MM--K412920; T2 Recon Lag Screw 6.5x95MM--K454330; T2 Recon Lag Screw 6.5x95MM--K488720; T2 Recon Lag Screw 6.5x95MM--K519401; T2 Recon Lag Screw 6.5x95MM--K519402; T2 Recon Lag Screw 6.5x95MM--K519405; T2 Recon Lag Screw 6.5x95MM--K519406; T2 Recon Lag Screw 6.5x95MM--K519407; T2 Recon Lag Screw 6.5x95MM--K519408; T2 Recon Lag Screw 6.5x95MM--K669388; T2 Recon Lag Screw 6.5x95MM--K678264; T2 Recon Lag Screw 6.5x95MM--K757954.  18976100S-- T2 Recon Lag Screw 6.5x100MM--K400122; T2 Recon Lag Screw 6.5x100MM--K454331; T2 Recon Lag Screw 6.5x100MM--K488721; T2 Recon Lag Screw 6.5x100MM--K519501; T2 Recon Lag Screw 6.5x100MM--K519502; T2 Recon Lag Screw 6.5x100MM--K519503; T2 Recon Lag Screw 6.5x100MM--K519504; T2 Recon Lag Screw 6.5x100MM--K519505; T2 Recon Lag Screw 6.5x100MM--K519508; T2 Recon Lag Screw 6.5x100MM--K519509; T2 Recon Lag Screw 6.5x100MM--K678265; T2 Recon Lag Screw 6.5x100MM--K678266; T2 Recon Lag Screw 6.5x100MM--K757955.  18976105S-- T2 Recon Lag Screw 6.5x105MM--K400123; T2 Recon Lag Screw 6.5x105MM--K454332; T2 Recon Lag Screw 6.5x105MM--K488751; T2 Recon Lag Screw 6.5x105MM--K519604; T2 Recon Lag Screw 6.5x105MM--K519605; T2 Recon Lag Screw 6.5x105MM--K519606; T2 Recon Lag Screw 6.5x105MM--K519607; T2 Recon Lag Screw 6.5x105MM--K519608; T2 Recon Lag Screw 6.5x105MM--K519609; T2 Recon Lag Screw 6.5x105MM--K519611; T2 Recon Lag Screw 6.5x105MM--K678267; T2 Recon Lag Screw 6.5x105MM--K678268; T2 Recon Lag Screw 6.5x105MM--K757974.  18976110S-- T2 Recon Lag Screw 6.5x110MM--K400124; T2 Recon Lag Screw 6.5x110MM--K454333; T2 Recon Lag Screw 6.5x110MM--K488758; T2 Recon Lag Screw 6.5x110MM--K519730; T2 Recon Lag Screw 6.5x110MM--K519731; T2 Recon Lag Screw 6.5x110MM--K519736; T2 Recon Lag Screw 6.5x110MM--K678269; T2 Recon Lag Screw 6.5x110MM--K757979.  18976115S-- T2 Recon Lag Screw 6.5x115MM--K400125; T2 Recon Lag Screw 6.5x115MM--K454334; T2 Recon Lag Screw 6.5x115MM--K488759; T2 Recon Lag Screw 6.5x115MM--K497822; T2 Recon Lag Screw 6.5x115MM--K519899; T2 Recon Lag Screw 6.5x115MM--K519900; T2 Recon Lag Screw 6.5x115MM--K519901; T2 Recon Lag Screw 6.5x115MM--K678271; T2 Recon Lag Screw 6.5x115MM--K678293.  18976120S-- T2 Recon Lag Screw 6.5x120MM--K400126; T2 Recon Lag Screw 6.5x120MM--K454335; T2 Recon Lag Screw 6.5x120MM--K520037; T2 Recon Lag Screw 6.5x120MM--K520038; T2 Recon Lag Screw 6.5x120MM--K520039; T2 Recon Lag Screw 6.5x120MM--K678294; T2 Recon Lag Screw 6.5x120MM--K678295; T2 Recon Lag Screw 6.5x120MM--K757980.  18976125S-- T2 Recon Lag Screw 6.5x125MM--K454336; T2 Recon Lag Screw 6.5x125MM--K488786; T2 Recon Lag Screw 6.5x125MM--K520139; T2 Recon Lag Screw 6.5x125MM--K520140; T2 Recon Lag Screw 6.5x125MM--K678296; T2 Recon Lag Screw 6.5x125MM--K678297; T2 Recon Lag Screw 6.5x125MM--K808190.  18976130S-- T2 Recon Lag Screw 6.5x130MM--K454337; T2 Recon Lag Screw 6.5x130MM--K520156; T2 Recon Lag Screw 6.5x130MM--K520157; T2 Recon Lag Screw 6.5x130MM--K520158; T2 Recon Lag Screw 6.5x130MM--K520159; T2 Recon Lag Screw 6.5x130MM--K520160; T2 Recon Lag Screw 6.5x130MM--K678298; T2 Recon Lag Screw 6.5x130MM--K678299; T2 Recon Lag Screw 6.5x130MM--K757982. 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactDominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.
FDA Determined
Cause 2		Other
ActionThe notification letters and product accountability forms were sent via FedEx on 8/12/2005 with return receipt.
Quantity in Commerce4698 PIECES
DistributionThe devices have been distributed to Stryker Branches/Agencies, Hospitals nationwide, and Government hospitals. There are no international customers.
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 = HSB
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