BEUDAMED
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    8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·August 19, 2015

    EZ-DOP, diagnostic ultrasound imaging system

    FDA Recall
    Terminated ·DWL Systems, Inc.·Product code IYN·January 5, 2004

    Oil Red O

    FDA classification
    FDA Class 1 ·Oil Red O

    SYNFIX® EVO PROTECTION SLEEVE 3-PACK F/SCREWDRIVER/AWL-STER

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·July 23, 2019

    SYNFIX® EVO PROTECTION SLEEVE 3-PACK F/SCREWDRIVER/AWL-STER

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·August 23, 2019

    Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amounts depending on order. Tray set is not sealed. These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. Tray catalog number is: Tray designated as ST0485-037.

    FDA Recall
    Terminated ·Aesculap, Inc.·Product code LRZ·November 10, 2015

    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.

    FDA Recall
    Terminated ·Orthofix, Inc·Product code MQP·November 19, 2009

    Media, Mounting, Oil Soluble

    FDA classification
    FDA Class 1 ·Media, Mounting, Oil Soluble

    Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442 RIC71173504 RIC71173505 RIC71631117 SMI21-0445 STR5800-4-125 STR60-13570 SYN03.010.060 SYN03.010.061 SYN03.010.101 SYN310.19 SYN310.24 SYN310.25 SYN310.288 SYN310.31 SYN310.35 SYN310.431 SYN310.44 SYN310.63 SYN310.65 SYN310.66 SYN310.67 SYN315.28 SYN315.40 SYN315.92 SYN317.861 SYN317.871 SYN356.982 SYN357.407 ZIM00-2318-020-00 and ZIM5056-146 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

    FDA Recall
    Terminated ·Sterilmed Inc·Product code HTW·August 8, 2008

    Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle); IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher; lT-RK1001 Rocker (Goal Post Style Tip); lT-BA1002 Vampire Awl; IT-RG1001 Rod Gripper, Ratcheting (Long Nose); IT-TP1001Tap, 4mm (Thin Style, Gold Tip); IT-TP1002 Tap, 5mm (Thin Style, Gold Tip) IT-TP1003 Tap, 6mm (Thin Style, Gold Tip); IT-TP1004 Tap, 7mm (Thin Style, Gold Tip); IT-SD 1002 Multiaxial Screwdriver (No Windows); IT-SD1005 Screwdriver Shaft 75 (w/BaIl Bearing); IT-CT1002 Counter Torque (Short No Windows); IT-SD1006 Multiaxial Screwdriver (w/Windows); IT-TP1005 Tap, 4mm (Silver Tn-Fluted); IT-TP1006 Tap, 5mm (Silver Tn-Fluted); IT-TP1007 Tap, 6mm (Silver Tn-Fluted); IT-TP1008 Tap, 7mm (Silver Tn-Fluted); lT-HP1002 Head Positioner (All Metal Handle); IT-RK1002 Rocker (Horse Shoe Style Tip); IT-SD1007 Screwdriver Shaft 8.5 (w/Ball Bearing); IT-CT1003 Counter Torque (Short w/Windows); IT-TP1014 Tap, 4mm (Silver Circumferential); IT-TP1015 Tap, 5mm (Silver Circumferential); IT-TP1016 Tap, 6mm (Silver Circumferential); IT-TP1017 Tap, 7mm (Silver Circumferential); IT-SD1007 Screwdriver Shaft 8.5 (No Ball Bearing); IT-XR1001 Extension Remover; IT-S01006 Screwdriver_Shaft 10 (No Ball Bearing); IT-FB1001 French Rod Bender; IT-SP1001 Ball Tip Probe; IT-TR1001 Trial Rod; IT-RG 1002 Rod Gripper, Ratcheting (Short Nose); IT-BP1003 Lumbar Probe, Straight (Long); IT-BP1004 Lumbar Probe, Curved (Long); IT-SP1002 Sounder (Ball Tip) Probe, Heavy Duty; RD-ST5540 Rod 5,5 x 400mm, Straight; IT-BA1001 Newport Awl; IT-PU 1001 Persuader; IT-RR1001 Retaining Ring; lT-NS1001 In-Situ Left; IT-N51002 In-Situ Right; IT-BP100S Lumbar Probe, Straight (Short); IT-BP1006 Lumbar Probe, Curved (Short); IT-CP1001 Compressor; IT-DT1001 Distractor; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic Ball Handle Probe, Straight; IT-RH1002 Ratcheting T-Handle; IT-NC1001 Locking Nut Caddy; IT-SG1001 Screw Gauge Block; IT-RH1002 Ratcheting Handle, Straight; IT-T01002 Preset Torque Wrench (With Connector); LG-LN1002 Locking Nut, Single Piece; LG-PR0530C Polyaxial Screw, Non-Winged, 5 X 30; LG-PR0535C Polyaxial Screw, Non-Winged, 5 X 35; LG-PR0540C Polyaxial Screw, Non-Winged, 5 X 40; LG-PR0545C Polyaxial Screw, Non-Winged, 5 X 45; LG-PR0550C Polyaxial Screw, Non-Winged, 5 X 50; LG-PR0630C Polyaxial Screw, Non-Winged, 6 X 30; LG-PR0635C Polyaxial Screw, Non-Winged, 6 X 35; LG-PR0640C Polyaxial Screw, Non-Winged, 6 X 40; LG-PR0645C Polyaxial Screw, Non-Winged, 6 X 45; LG-PR0650C Polyaxial Screw, Non-Winged, 6 X 50; LG-PR0730C Polyaxial Screw, Non-Winged, 7 X 30; LG-PR0735C Polyaxial Screw, Non-Winged, 7 X 35; LG-PR0740C Polyaxial Screw, Non-Winged, 7 X 40; LG-PR074SC Polyaxial Screw, Non-Winged, 7 X 45; LG-PR0750C Polyaxial Screw, Non-Winged, 7 X 50; LG-PR0755C Polyaxial Screw, Non-Winged, 7 X 55; LG-PR083SC Polyaxial Screw, Non-Winged, 8 X 35; LG-PR0840C Polyaxial Screw, Non-Winged, 8 X 40; LG-PR0845C Polyaxial Screw, Non-Winged, 8 X 45; LG-PR0850C Polyaxial Screw, Non-Winged, 8 X 50; LG-PR0855C Polyaxial Screw, Non-Winged, 8)( 55; LG-PW0535C Polyaxial Screw, Winged, S X 35; LG-PW0540C Polyaxial Screw, Winged, 5 X 40; LG-PW0545C Polyaxial Screw, Winged, 5 X 45; LG-PW0635C Polyaxial Screw, Winged, 6 X 35; LG-PW0640C Polyaxial Screw, Winged, 6 X 40; LG-PW0645C Polyaxial Screw, Winged, 6 X 45; LG-PW0735C Polyaxial Screw, Winged, 7 X 35; LG-PW0740C Polyaxial Screw, Winged, 7 X 40; LG-PW0745C Polyaxial Screw, Winged, 7 X 45; RD-PB5504 ROD 5.5 X 40, PRE-BENT; RD-PB5505 ROD 5.5 X 50, PRE-BENT; RD-PB5506 ROD 5.5 X 60, PRE-BENT; RD-PB5507 ROD 5.5 X 70, PRE-BENT; RD-PB5508 ROD 5.5 X 80, PRE-BENT; RD-PB5509 ROD 5.5 X 90, PRE-BENT; RD-PB5510 ROD 5.5 X 100, PRE-BENT; RD-PB5511 ROD 5.5 X 110, PRE-BENT; RD-PB5

    FDA Recall
    Terminated ·Allez Spine, LLC·Product code NKB·August 21, 2008

    Oil Emulsion/Thymolphthalein (Titrimetric), Lipase

    FDA classification
    FDA Class 1 ·Oil Emulsion/Thymolphthalein (Titrimetric), Lipase

    Olive Oil Emulsion (Turbidimetric), Lipase

    FDA classification
    FDA Class 1 ·Olive Oil Emulsion (Turbidimetric), Lipase

    Apparatus, Electronanesthesia

    FDA classification
    FDA Class 3 ·Apparatus, Electronanesthesia

    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

    FDA classification
    FDA Class 2 ·Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

    Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.

    FDA Recall
    Terminated ·Helix Medical LLC·Product code EWL·March 8, 2012

    DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code DWL·March 19, 2014

    Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

    FDA Recall
    Terminated ·Helix Medical LLC·Product code EWL·October 1, 2013