Drugs & medicalClass II

Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

Potential packaging breaches of inner blister and outer sterile blister.

Read the official notice →
Date
2024-03-13
Country
United States
Brand
Howmedica Osteonics
Product
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Classification
Class II
Units
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Howmedica Osteonics recalls

  1. 2024-07-24
  2. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043

    Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the…

    FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice →
  3. 2024-06-26
  4. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910

    The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including…

    FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  5. 2024-05-01
  6. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F

    The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

    FDA · DeviceHowmedica Osteonics Corp.Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UKOfficial notice →
  7. 2024-02-14
  8. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty

    Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility

    FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
  9. 2024-02-07
  10. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910

    Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

    FDA · DeviceHowmedica Osteonics Corp.Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China,…Official notice →
  11. 2023-06-21
  12. US
    Drugs & medicalClass II

    Howmedica Osteonics Corp. recalls Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026

    The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.

    FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of Ireland.Official notice →
All 28 Howmedica Osteonics recalls →

Other drugs & medical recalls in the United States

  1. 2024-03-20
  2. US
    Drugs & medicalClass II

    SUN PHARMACEUTICAL INDUSTRIES INC recalls Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141,…

    CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

    FDA · DrugSUN PHARMACEUTICAL INDUSTRIES INCNationwideOfficial notice →
  3. 2024-03-13
  4. US
    Drugs & medicalClass II

    ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.

    The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.

    FDA · DeviceConvaTec, IncDistribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX.…Official notice →
  5. US
    Drugs & medicalClass II

    FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.2.100

    Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.

    FDA · DeviceFUJIFILM Healthcare Americas CorporationWorldwide distribution - US Nationwide, including Puerto Rico and the…Official notice →
  6. US
    Drugs & medicalClass II

    Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm)

    The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL and LA.Official notice →
  7. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R

    Medical devices distributed, prior to sterilization

    FDA · DeviceParagon 28, Inc.US:CA OUS: NoneOfficial notice →
  8. US
    Drugs & medicalClass II

    Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the…

    European version of microcatheter were distributed within US which contain a different "Indications for Use".

    FDA · DeviceMicro Therapeutics, Inc.US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, HI, IA,…Official notice →
See all drugs & medical recalls →