Drugs & medicalClass II

Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420…

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue…

Read the official notice →
Date
2025-12-31
Country
United States
Brand
Zimmer
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420…
Classification
Class II
Units
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Zimmer recalls

  1. 2026-07-01
  2. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10…

    Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

    FDA · DeviceZimmer, Inc.Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA…Official notice →
  3. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

    Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.

    FDA · DeviceZimmer, Inc.US Nationwide distribution.Official notice →
  4. 2026-05-06
  5. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software…

    Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to…

    FDA · DeviceZimmer, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice →
  6. 2025-11-12
  7. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number:…

    Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package…

    FDA · DeviceZimmer, Inc.US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS,…Official notice →
  8. 2025-04-30
  9. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained,…

    The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

    FDA · DeviceZimmer, Inc.Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong,…Official notice →
  10. 2025-04-02
  11. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

    The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

    FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME,…Official notice →
All 21 Zimmer recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-31
  2. US
    Drugs & medicalClass II

    Cook Incorporated recalls Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3)…

    Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not…

    FDA · DeviceCook IncorporatedWorldwide distribution.Official notice →
  3. US
    Drugs & medicalClass II

    Diasol, Inc recalls Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

    Safety and efficacy of dialysis acid concentrate cannot be assured

    FDA · DeviceDiasol, IncUS Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.Official notice →
  4. US
    Drugs & medicalClass II

    Microbiologics Inc recalls KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

    Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

    FDA · DeviceMicrobiologics IncWorldwide - US Nationwide.Official notice →
  5. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

    Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they…

    FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA,…Official notice →
  6. US
    Drugs & medicalClass II

    ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

    For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do…

    FDA · DeviceICU Medical, Inc.US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.Official notice →
  7. US
    Drugs & medicalClass II

    Intuitive Surgical, Inc. recalls da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40

    Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be…

    FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC,…Official notice →
See all drugs & medical recalls →