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 510 of 1191
FDA device recalls, page 510 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0570-2018Class IIPerifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024. Local...B Braun Medical IncFMI
Z-0569-2018Class IIPencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin...B Braun Medical IncFMI
Z-0568-2018Class IIPerifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local...B Braun Medical IncFMI
Z-0567-2018Class IIPerifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266...B Braun Medical IncFMI
Z-3016-2017Class IIPALLAS M/MAXIMIS Rod Pusher B. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3015-2017Class IIPALLAS M/MAXIMIS Guide Wire. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3014-2017Class IIPALLAS M/MAXIMIS Set Screw Starter. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3013-2017Class IIPALLAS M/MAXIMIS Persuader. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3012-2017Class IIPALLAS M/MAXIMIS Driver Shaft (5Hex, Set Screw) 1/4 inch Drive. Part of MAXIMIS Pedicle...Valorem SurgicalMNI
Z-3011-201Class IIPALLAS M/MAXIMIS Body Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-3010-2017Class IIPALLAS M/MAXIMIS C. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-3009-2017Class IIPALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-3008-2017Class IIPALLAS M/MAXIMIS Nut Inserter B. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3007-2017Class IIPALLAS M/MAXIMIS Head Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3006-2017Class IIPALLAS M/MAXIMIS MISS/MIS Tapper 7.5 mm. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-3005-2017Class IIPALLAS M/MAXIMIS MIS Anti Torque. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3004-2017Class IIPALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-3003-2017Class IIPALLAS M/MAXIMIS Ratchet T Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3002-2017Class IIPALLAS M/MAXIMIS Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3001-2017Class IIPALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-3000-2017Class IIPALLAS M/MAXIMIS Rod Checker and T-Bar. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2999-2017Class IIPALLAS M/MAXIMIS MIS Alignment Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2998-2017Class IIPALLAS M/MAXIMIS MISS/MIS Compressor and Rod Tightener. Part of MAXIMIS Pedicle Screw...Valorem SurgicalMNI
Z-2997-2017Class IIPALLAS M/MAXIMIS Rod Gauge. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2996-2017Class IIPALLAS M/MAXIMIS Rod Checker. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2995-2017Class IIPALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2994-2017Class IIPALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pedicle Screw...Valorem SurgicalMNI
Z-2993-2017Class IIPALLAS M/MAXIMIS Anti Torque Device. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2992-2017Class IIPALLAS M/MAXIMIS MISS/MIS Poly Screw Driver. Part of MAXIMIS Pedicle Screw Spinal...Valorem SurgicalMNI
Z-2991-2017Class IIPALLAS M/MAXIMIS Compass. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem...Valorem SurgicalMNI
Z-2990-2017Class IIPALLAS M/MAXIMIS Extension Sleeve. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2989-2017Class IIPALLAS M/MAXIMIS Extension Guide Bush. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2988-2017Class IIPALLAS M/MAXIMIS Extension Driver. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2987-2017Class IIPALLAS M/MAXIMIS Extension Block. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2986-2017Class IIPALLAS M/MAXIMIS Closed Extension. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2985-2017Class IIPALLAS M/MAXIMIS Open Extension (Large). Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2984-2017Class IIPALLAS M/MAXIMIS Open Extension (Small). Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2983-2017Class IIPALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2982-2017Class IIPALLAS M/MAXIMIS MIS Tapper 5.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2981-2017Class IIPALLAS M/MAXIMIS MIS Pedicle Cut. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2980-2017Class IIPALLAS M/MAXIMIS Dilator B. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2979-2017Class IIPALLAS M/MAXIMIS Dilator A. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2978-2017Class IIPALLAS M/MAXIMIS Dilator Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2977-2017Class IIPALLAS M/MAXIMIS Cross Link Torque Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2976-2017Class IIPALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2975-2017Class IIPALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI
Z-2974-2017Class IIPALLAS M/MAXIMIS Inside Bender (L) and (R). Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2973-2017Class IIPALLAS M/MAXIMIS Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2972-2017Class IIPALLAS M/MAXIMIS Marking Pin (Smooth). Part of MAXIMIS Pedicle Screw Spinal Fixation...Valorem SurgicalMNI
Z-2971-2017Class IIPALLAS M/MAXIMIS Distractor. Part of MAXIMIS Pedicle Screw Spinal Fixation System...Valorem SurgicalMNI