Drugs & medicalClass II

Wright Medical Technology, Inc. recalls Wright EVOLVE TRIAD Plate Cutter, REF 49510120

The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

Read the official notice →
Date
2022-07-20
Country
United States
Brand
Wright Medical Technology
Product
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Classification
Class II
Units
Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Wright Medical Technology recalls

  1. 2022-11-02
  2. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3

    The tibial tray lock detail is oversized (larger than specification).

    FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution in the state of New York.Official notice →
  3. 2022-10-12
  4. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System…

    The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm…

    FDA · DeviceWright Medical Technology, Inc.US Nationwide distribution.Official notice →
  5. 2022-08-31
  6. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00, REF 4700020, Sterile.

    An incorrect sizing label was applied to the carton packaging.

    FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →
  7. 2022-07-06
  8. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total…

    The instrument is incorrectly color coded.

    FDA · DeviceWright Medical Technology, Inc.Worldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice →
  9. 2022-04-06
  10. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls EasyFuse Dynamic Compression System Instrument Pack

    The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

    FDA · DeviceWright Medical Technology, Inc.US distribution to Florida, North Carolina, Ohio, and TexasOfficial notice →
  11. 2022-03-23
  12. US
    Drugs & medicalClass II

    Wright Medical Technology, Inc. recalls Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC…

    An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

    FDA · DeviceWright Medical Technology, Inc.International distribution to the country of France.Official notice →
All 16 Wright Medical Technology recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-20
  2. US
    Drugs & medicalClass III

    Invacare Corporation recalls Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)

    Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.

    FDA · DeviceInvacare CorporationDomestic distribution to the following states: ALASKA ARIZONA CALIFORNIA…Official notice →
  3. US
    Drugs & medicalClass II

    Ultradent Products, Inc. recalls Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch Intro Kit, Part: 4554; Peak SE Primer 4pk Refill,…

    SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.

    FDA · DeviceUltradent Products, Inc.Worldwide distribution - US Nationwide distribution in the states of Florida,…Official notice →
  4. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS¿…

    On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU).

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Colombia, India,…Official notice →
  5. US
    Drugs & medicalClass II

    Draeger Medical Systems, Inc. recalls Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. neonatal transport system

    The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system.

    FDA · DeviceDraeger Medical Systems, Inc.No US distribution. Foreign distribution to BY, CL, DE, ES, GB, HU, IN, IT,…Official notice →
  6. US
    Drugs & medicalClass II

    Fresenius Medical Care Holdings, Inc. recalls AquaBplus Water Purification System, Part Number 24-2000-0, AquaBplus 2500 - Typ USA (G02040108-US), AquaBplus 2000 - Typ…

    AquaBplus HF module on the AquaBplus 2000 osmosis system, an error in the US Installation Guideline instructed that 3-ring mains, instead of 2-ring mains, may be installed in combination with an AquaBplus 2000 device.…

    FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the states of NC and WV.Official notice →
  7. US
    Drugs & medicalClass II

    Cordis US Corp recalls PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.

    Potential for stent dislodgement and associated failures related to two specific sizes of the device.

    FDA · DeviceCordis US CorpUS Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
See all drugs & medical recalls →