Devices

Device Recall Guide Wire

  • Model / Serial
    .045 X 6 ST Guide Wire Lot number: 391681  .054 X 7 ST Guide Wire Lot number: 391680
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in Great Britain, Ireland, and Japan only.
  • Product Description
    .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. || .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. || These guide wires are an orthopedic manual surgical instrument.
  • Manufacturer
    Acumed LLC
  • 1 Event

Manufacturer

Acumed LLC
  • Manufacturer Address
    Acumed LLC, 5885 NW Cornelius Pass Rd, Hillsboro OR 97124-9432
  • Manufacturer Parent Company (2017)
    Acumed Llc
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall Guide wire
  • Model / Serial
    OEM Catalog number 38931-04.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in DC and the states of CO, CA, FL, TX, and AR.
  • Product Description
    Medical Device Exchange PT WIRE 300; || Pouch, Tyvek/Mylar, Sterile, Single Use Only; || OEM Catalog number 38931-04; || EXP (repackager), Boston Scientific (OEM) || Wire, guide, catheter
  • Manufacturer
    EXP Pharmaceutical Services Corp
Device Recall Guide Wires and KWires for T2 and Gamma Systems
  • Model / Serial
    Catalog number 0152-0218S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Stryker, T2 K-Wire 1.8 x 310 mm, Sterile || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Guide Wires and KWires for T2 and Gamma System
  • Model / Serial
    Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Stryker, Gamma K-Wire 3.2x450 mm || Product Usage: || Intended for the temporary stabilization of bone segments or fragments.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall GUIDE WIRE w/ BALL TIP 2.0MMX98CM
  • Model / Serial
    228829 311230 311260 255105 152590 757210 982070 282057 283729 057650 292980 293094 299420 668040 579470 354970 519980 670820 695640 963100
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and Netherlands.
  • Product Description
    GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 || Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
  • Manufacturer
    Zimmer Biomet, Inc.