Drugs & medicalClass II

Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

Due to Titanium plasma coating not present implant.

Read the official notice →
Date
2022-08-03
Country
United States
Brand
Paragon
Product
HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Classification
Class II
Units
U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Paragon recalls

  1. 2026-08-26
  2. US
    Drugs & medicalClass III

    Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

    Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

    FDA · DeviceParagon 28, Inc.US Nationwide distribution i the state of MT.Official notice →
  3. 2026-07-29
  4. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number…

    Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

    FDA · DeviceParagon 28, Inc.US nationwide, Australia, Canada, The Netherlands, and New ZealandOfficial notice →
  5. 2025-12-10
  6. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

    Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting…

    FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX,…Official notice →
  7. 2024-03-13
  8. 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 →
  9. 2022-09-28
  10. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

    Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.

    FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD,…Official notice →
  11. 2022-08-03
  12. US
    Drugs & medicalClass II

    Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

    Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

    FDA · DeviceParagon 28, Inc.International distribution in the country of UK.Official notice →
All 7 Paragon recalls →

Other drugs & medical recalls in the United States

  1. 2022-08-03
  2. US
    Drugs & medicalClass II

    Stryker Instruments recalls Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

    There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical…

    FDA · DeviceStryker InstrumentsWorldwide distribution - US Nationwide distribution in the states of Arizona,…Official notice →
  3. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - SPT recalls Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number…

    Kits contain leaking bottles of isopropyl alcohol

    FDA · DeviceMEDLINE INDUSTRIES, LP - SPTUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    SIGHT DIAGNOSTICS LTD recalls Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

    The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may…

    FDA · DeviceSIGHT DIAGNOSTICS LTDWorldwide distribution - US Nationwide distribution in the states of Alabama,…Official notice →
  5. US
    Drugs & medicalClass II

    Covidien Llc recalls TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number:…

    Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.

    FDA · DeviceCovidien LlcAZ CA CO IL KS MA MI MN MO NY OK PA TN TX TX WA Foreign: United Kingdom…Official notice →
  6. US
    Drugs & medicalClass II

    GE Healthcare, LLC recalls Centricity PACS Software Version 7.0 SP0.0.4.7

    The Event Notification Manager (ENM) functionality for certain products does not process notifications for study modifications performed on post verified exams.

    FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of CO, NV,…Official notice →
  7. US
    Drugs & medicalClass III

    Zeiss, Carl Inc recalls ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000

    An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.

    FDA · DeviceZeiss, Carl IncUS Nationwide distribution in the state of NY.Official notice →
See all drugs & medical recalls →