Drugs & medicalClass II

Nextremity Solutions recalls Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of…

During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in…

Read the official notice →
Date
2022-03-16
Country
United States
Brand
Nextremity Solutions
Product
Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of…
Classification
Class II
Units
US Nationwide distribution in the states of AZ, IL, GA, LA, MD, NY, PA, TX, WA.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Nextremity Solutions recalls

  1. 2022-04-20
  2. US
    Drugs & medicalClass II

    Nextremity Solutions recalls Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument

    Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

    FDA · DeviceNextremity SolutionsDistribution US Nationwide, Japan, and the NetherlandsOfficial notice →
All 2 Nextremity Solutions recalls →

Other drugs & medical recalls in the United States

  1. 2022-03-16
  2. US
    Drugs & medicalClass II

    3-D Matrix, Inc. recalls PuraSinus Absorbable Nasal Hemostat, Part Numbers 651-006

    The boxes used by the shipper were not validated for use during transport.

    FDA · Device3-D Matrix, Inc.US Nationwide distribution in the state OH.Official notice →
  3. US
    Drugs & medicalClass II

    Medtronic Xomed, Inc. recalls NIM TRIVANTAGE EMG Endotracheal Tube

    There is potential for multiple issues due to a manufacturing nonconformity.

    FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide and the countries of Algeria,…Official notice →
  4. US
    Drugs & medicalClass II

    Cytocell Ltd. recalls Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog…

    individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 probe is labelled in green rather than red and the control…

    FDA · DeviceCytocell Ltd.US Nationwide distribution in the states of Hawaii, Missouri, Pennsylvania,…Official notice →
  5. US
    Drugs & medicalClass II

    NeuMoDx Molecular Inc recalls NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in…

    A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.

    FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MD, MI, NY.Official notice →
  6. US
    Drugs & medicalClass II

    Bolder Surgical, LLC recalls CoolSeal Generator, REF: CSL-200-50

    A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of…

    FDA · DeviceBolder Surgical, LLCUS: NY, MO, DE, PA, FL OUS: Italy, Chile, UKOfficial notice →
  7. US
    Drugs & medicalClass II

    Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales unit is composed of 1000 tips per box.

    The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact…

    FDA · DeviceOrtho-Clinical Diagnostics, Inc.Domestic distribution nationwide. Foreign distribution to Canada.Official notice →
See all drugs & medical recalls →