Drugs & medicalClass II

New Standard Device Inc recalls 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System

1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.

Read the official notice →
Date
2022-06-15
Country
United States
Brand
New Standard Device
Product
1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
Classification
Class II
Units
US Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More New Standard Device recalls

  1. 2023-06-21
  2. US
    Drugs & medicalClass II

    New Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805

    The threads on posts stripping out when tensioned during application process.

    FDA · DeviceNew Standard Device IncU.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.Official notice →
  3. 2022-09-07
  4. US
    Drugs & medicalClass II

    New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin…

    Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

    FDA · DeviceNew Standard Device IncU.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: NoneOfficial notice →
  5. 2022-06-29
  6. US
    Drugs & medicalClass II

    New Standard Device Inc recalls Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A

    Due to manufacturing processing error, wrench causing stripping when torqueing nuts.

    FDA · DeviceNew Standard Device IncU.S.: AZ. CT, GA, OH, and VA O.U.S.: N/AOfficial notice →
All 4 New Standard Device recalls →

Other drugs & medical recalls in the United States

  1. 2022-06-15
  2. US
    Drugs & medicalClass II

    Oakworks Inc recalls Oakworks Bed (Emergency Field Bed); Model No. OBMPBR361980A6TTGRCS

    The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

    FDA · DeviceOakworks IncUS Nationwide distribution in the states of MA, NJ, and PA.Official notice →
  3. US
    Drugs & medicalClass II

    Oakworks Inc recalls PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C19

    Product label was printed without the UDI number and warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.

    FDA · DeviceOakworks IncUS Nationwide distribution in the states of MA, NJ, and PA.Official notice →
  4. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog…

    Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

    FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN,…Official notice →
  5. US
    Drugs & medicalClass II

    Northgate Technologies, Inc. recalls AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

    Product labeled incorrectly.

    FDA · DeviceNorthgate Technologies, Inc.US Nationwide distribution in the state of MA.Official notice →
  6. US
    Drugs & medicalClass II

    Karl Storz Endoscopy recalls STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF…

    The endoscope may experience a loss of image when activating monopolar electrocautery, due a manufacturing assembly process issue.

    FDA · DeviceKarl Storz EndoscopyWorldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice →
  7. US
    Drugs & medicalClass II

    GE Healthcare, LLC recalls Centricity Radiology RA600

    Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values…

    FDA · DeviceGE Healthcare, LLCWorldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC,…Official notice →
See all drugs & medical recalls →