510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,476 records, page 906 of 1190
FDA device recalls, page 906 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0684-20112.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0683-20112.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0682-20111.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0681-20111.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0680-20111.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0679-20111.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0678-20112.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1216, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0677-20112.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1215, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0676-20112.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1214, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0675-20112.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1213, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0674-20112.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0673-20112.0 mm Inion CPS Baby, 2.0 x 7 mm screw, REF SCR-1211, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0672-20112.0 mm Inion CPS Baby, 2.0 x 5 mm screw, REF SCR-1210, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0671-20112.8 mm Inion CPS, 2.8 x 23 mm screw, REF SCR-1209, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0670-20112.5 mm Inion CPS, 2.5 x 23 mm screw, REF SCR-1208, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0669-20112.5 mm Inion CPS, 2.5 x 8 mm screw, REF SCR-1207, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0668-20112.5 mm Inion CPS, 2.5 x 6 mm screw, REF SCR-1206, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0667-20111.5 mm Inion CPS Baby, X-plate, large, REF PLT-1062, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0666-20111.5 mm Inion CPS Baby, 64 hole plate, REF PLT-1059, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0665-20112.5 mm Inion CPS, 4 hole plate, extended long, REF PLT-1041, sterile, Manufacturer...Stryker Craniomaxillofacial DivisionJEY
Z-0664-20112.0 mm Inion CPS, L-plate left, 7 holes, REF PLT-1040, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0663-20112.0 mm Inion CPS, L-plate right, 7 holes, REF PLT-1039, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0662-20112.0 mm Inion CPS, 6 hole plate, REF PLT-1038, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0661-20112.0 mm Inion CPS, X-plate, 7 holes, REF PLT-1037, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0660-20112.5 mm Inion CPS, 10 hole plate, REF PLT-1036, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0659-20112.5 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1035, sterile, Manufacturer, INION...Stryker Craniomaxillofacial DivisionJEY
Z-0658-20112.5 mm Inion CPS, Mesh plate 7 x 7 holes, REF PLT-1034, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0657-20112.0 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1033, sterile, Manufacturer, INION...Stryker Craniomaxillofacial DivisionJEY
Z-0656-20112.0 mm Inion CPS, Mesh plate 7 x7 holes, REF PLT-1032, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0655-20111.5 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1031, sterile, Manufacturer, INION...Stryker Craniomaxillofacial DivisionJEY
Z-0654-20111.5 mm Inion CPS, Mesh plate 7 x 7 10 holes, REF PLT-1030, sterile, Manufacturer, INION...Stryker Craniomaxillofacial DivisionJEY
Z-0653-20111.5 mm Inion CPS Baby, Mesh plate 14 x 14 holes, REF PLT-1029, sterile, Manufacturer...Stryker Craniomaxillofacial DivisionJEY
Z-0652-20111.5 mm Inion CPS Baby, mesh plate 7 x 7 holes, REF PLT-1028, sterile, Manufacturer...Stryker Craniomaxillofacial DivisionJEY
Z-0651-20112.5 mm Inion CPS, 8 hole plate, REF PLT-1027, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0650-20112.5 mm Inion CPS, 6 hole plate,extended, REF PLT-1026, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0649-20112.5 mm Inion CPS, 6 hole plate, REF PLT-1025, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0648-20112.5 mm Inion CPS, 4 hole plate, extended, REF PLT-1024, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0647-20112.5 mm Inion CPS, 4 hole plate, REF PLT-1023, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0646-20112.0 mm Inion CPS, C-plate, 7 holes, REF PLT-1017, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0645-20112.0 mm Inion CPS, 10 hole plate, REF PLT-1016, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0644-20112.0 mm Inion CPS, 4-hole plate, extended, REF PLT-1014, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0643-20112.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0642-20111.5 mm Inion CPS, X-plate, 7 holes, REF PLT-1012, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0641-20111.5 mm Inion CPS, Burrhole plate, REF PLT-1011, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0640-20111.5 mm Inion CPS, L-plate left, 7 holes, REF PLT-1010, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0639-20111.5 mm Inion CPS, L-plate right, 7 holes, REF PLT-1009, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0638-20111.5 mm Inion CPS, C-plate, 7 holes, REF PLT-1008, sterile, Manufacturer, INION Oy...Stryker Craniomaxillofacial DivisionJEY
Z-0637-20111.5 mm Inion CPS, 20 hole plate, REF PLT-1007, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0636-20111.5 mm Inion CPS, 6 hole plate, REF PLT-1006, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY
Z-0635-20111.5 mm Inion CPS, 4 hole plate, REF PLT-1005, sterile, Manufacturer, INION Oy, Finland.Stryker Craniomaxillofacial DivisionJEY