Recalls / —

—#41453

Product

T2 Recon Nail System.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032898
Affected lot / code info: 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.

Why it was recalled

The blister pack containing the Recon 6.5 Lag Screws may become damage during shipment resulting in loss of sterility.

Root cause (FDA determination)

Other

Action the firm took

The notification letters and product accountability forms were sent via FedEx on 8/12/2005 with return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: The devices have been distributed to Stryker Branches/Agencies, Hospitals nationwide, and Government hospitals. There are no international customers.

Timeline

Recall initiated: 2005-08-12
Posted by FDA: 2005-10-15
Terminated: 2006-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #41453. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.