Devices

Drill Bits

  • Model / Serial
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Product Description
    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.
  • Manufacturer
    Sterilmed Inc
  • 1 Event

Manufacturer

Sterilmed Inc
  • Manufacturer Address
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA

33 devices with a similar name

Learn more about the data here

Instruments - Drill bits
  • Model / Serial
    Model: , Affected: S -0088, S -0089, S-0090, S -0091
  • Manufacturer
    CareFusion Inc
drill bits for omeralis aequalis nails
  • Model / Serial
  • Product Description
    md
  • Manufacturer
    TORNIER
Device Recall Cannulated Drill Bits
  • Model / Serial
    Part Number  310.65 310.67 310.221  lot numbers  PE00966  PE01000 PE01039 PE01058 PE00959  PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971  PE01059 PE01040
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Canada.
  • Product Description
    3.2 mm Cannulated Drill Bit/ QC 170 mm || 2.7 Cannulated Drill Bit/ QC 160 mm || 2.0 mm Cannulated Drill Bit / QC 150 mm || there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
  • Manufacturer
    Synthes, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63562129, 63578148, 63377521, 63398755, 63415317, 63431736, 63438195, 63438272, 63444661, 63462322, 63474385, 63485128, 63497202, 63505360, 63510813, 63524432 & 63530407.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall ECT Internal Fracture Fixation Drill Bits
  • Model / Serial
    Lot Numbers: 63545279, 63610791, 63641572, 63333729, 63333730, 63333732, 63340531, 63364064, 63364065, 63372902, 63384626, 63384629, 63444670, 63444671, 63457776, 63457945, 63462343, 63462344, 63474390, 63497205, 63497206, 63505362, 63510815, 63535517, 63535518 & 63722007.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Product Description
    ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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