510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,528 records, page 511 of 1191
FDA device recalls, page 511 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2970-2017Class IIPALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2969-2017Class IIPALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2968-2017Class IIPALLAS M/MAXIMIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2967-2017Class IIPALLAS M/MAXIMIS Rod Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2966-2017Class IIPALLAS M/MAXIMIS Nut Driver 4.0 Hexa and Alignment Driver. Part of MAXIMIS Pedicle Screw...Valorem SurgicalMNI
Z-2965-2017Class IIPALLAS M/MAXIMIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2964-2017Class IIPALLAS M/MAXIMIS Wall Check. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2963-2017Class IIPALLAS M/MAXIMIS Tapper 6.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2962-2017Class IIPALLAS M/MAXIMIS Tapper 5.5. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2961-2017Class IIPALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-2960-2017Class IIPALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2959-2017Class IIPALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2958-2017Class IIPALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2957-2017Class IIPALLAS M/MAXIMIS 40mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-2956-2017Class IIPALLAS M/MAXIMIS 300mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2955-2017Class IIPALLAS M/MAXIMIS 35mm Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-2954-2017Class IIPALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2953-2017Class IIPALLAS M/MAXIMIS 80mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2952-2017Class IIPALLAS M/MAXIMIS 70mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2951-2017Class IIPALLAS M/MAXIMIS 60mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2950-2017Class IIPALLAS M/MAXIMIS 50mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2949-2017Class IIPALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2948-2017Class IIPALLAS M/MAXIMIS 40mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2947-2017Class IIPALLAS M/MAXIMIS 35mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2946-2017Class IIPALLAS M/MAXIMIS 80mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2945-2017Class IIPALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2944-2017Class IIPALLAS M/MAXIMIS 60mm Curved and Precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal...Valorem SurgicalMNI
Z-2943-2017Class IIPALLAS M/MAXIMIS 50mm Curved and precontoured Rod. Part of MAXIMIS Pedicle Screw Spinal...Valorem SurgicalMNI
Z-2942-2017Class IIPALLAS M/MAXIMIS 45mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2941-2017Class IIPALLAS M/MAXIMIS MIS Screw 5.5 x 40mm and 5.5 x 4.0 mm screw. Part of MAXIMIS Pedicle...Valorem SurgicalMNI
Z-2940-2017Class IIPALLAS M/MAXIMIS 35mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2939-2017Class IIPALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2938-2017Class IIPALLAS M/MAXIMIS Poly Screw 6.5 x 50mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2937-2017Class IIPALLAS M/MAXIMIS Poly Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2936-2017Class IIPALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2935-2017Class IIPALLAS M/MAXIMIS Poly Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2934-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2933-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2932-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2931-2017Class IIPALLAS M/MAXIMIS Poly Screw 5.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2633-2017Class IIMOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ...Elekta LimitedIYE
Z-2930-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS Pedicle...Valorem SurgicalMNI
Z-2929-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS Pedicle...Valorem SurgicalMNI
Z-2928-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2927-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 40mm and 6.5 x 4.0 mm screw. Part of MAXIMIS Pedicle...Valorem SurgicalMNI
Z-2926-2017Class IIPALLAS M/MAXIMIS MIS Screw 6.5 x 35mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2925-2017Class IIPALLAS M/MAXIMIS MIS Screw5.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2924-2017Class IIPALLAS M/MAXIMIS MIS Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMIS Pedicle...Valorem SurgicalMNI
Z-2923-2017Class IIPALLAS M/MAXIMIS MIS Screw 5.5 x 45mm & 5.5 x 4.0mm, and 7.5 x 45mm. Part of MAXIMIS...Valorem SurgicalMNI
Z-2922-2017Class IIPALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI