Drugs & medicalClass II

Smith & Nephew, Inc. recalls Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic…

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

Read the official notice →
Date
2022-02-16
Country
United States
Brand
Smith & Nephew
Product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic…
Classification
Class II
Units
Worldwide distribution - US Nationwide distribution in the states of CO, CT,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Smith & Nephew recalls

  1. 2023-04-26
  2. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

    A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

    FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.Official notice →
  3. 2022-07-27
  4. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left,…

    The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

    FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO,…Official notice →
  5. 2022-05-25
  6. US
    Drugs & medicalClass II

    Smith & Nephew Inc recalls LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

    It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

    FDA · DeviceSmith & Nephew IncWorldwide distribution - US Nationwide distribution in the states of CT, NC,…Official notice →
  7. 2022-02-09
  8. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

    The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

    FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CA and OH.Official notice →
  9. 2021-12-22
  10. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

    Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large…

    FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ,…Official notice →
  11. 2021-11-24
  12. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

    The labels on the packages of screws were switched.

    FDA · DeviceSmith & Nephew, Inc.Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME,…Official notice →
All 22 Smith & Nephew recalls →

Other drugs & medical recalls in the United States

  1. 2022-02-23
  2. US
    Drugs & medicalClass II

    Lannett Company, Inc. recalls Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc.,…

    Failed Impurities/Degradation Specifications: Out of specification results for related substances.

    FDA · DrugLannett Company, Inc.Product was distributed nationwide in the USA.Official notice →
  3. 2022-02-17
  4. US
    Drugs & medical

    Zeno Recalls Infant Walkers Due to Fall and Entrapment Hazards (Recall Alert)

    The infant walkers fail to meet the federal safety standard. They can fit through a standard doorway and are not designed to stop at the edge of a step as required by the federal safety standard. The walkers also have…

    CPSCAbout 1,355Official notice →
  5. 2022-02-16
  6. US
    Drugs & medicalClass III

    Microbiologics Inc recalls LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single…

    Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

    FDA · DeviceMicrobiologics IncInternational distribution in the countries of Canada and Germany.Official notice →
  7. US
    Drugs & medicalClass II

    Synthes (USA) Products LLC recalls Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the…

    Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not…

    FDA · DeviceSynthes (USA) Products LLCUS Nationwide distribution.Official notice →
  8. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls CURAD REUSABLE GEL HOT/COLD PACK

    The product contains natural rubber latex but the label states that it does not.

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS and Bahamas, Bermuda, Panama, Lebanon, Barbados, Honduras, AnguillaOfficial notice →
  9. US
    Drugs & medicalClass II

    DePuy Orthopaedics, Inc. recalls ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product…

    May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.

    FDA · DeviceDePuy Orthopaedics, Inc.US Nationwide distribution in the states of TN, TX.Official notice →
See all drugs & medical recalls →