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.

Read the official notice →
Date
2022-02-16
Country
United States
Brand
DePuy Orthopaedics
Product
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product…
Classification
Class II
Units
US Nationwide distribution in the states of TN, TX.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 DePuy Orthopaedics recalls

  1. 2023-03-29
  2. US
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    DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118

    The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to…

    FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Poland,…Official notice →
  3. 2022-07-27
  4. US
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    DePuy Orthopaedics, Inc. recalls ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant…

    Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical…

    FDA · DeviceDePuy Orthopaedics, Inc.Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil,…Official notice →
  5. 2022-07-20
  6. US
    Drugs & medicalClass II

    DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000,…

    The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should…

    FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  7. 2022-05-11
  8. US
    Drugs & medicalClass II

    DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100

    System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment

    FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Israel, Australia…Official notice →
  9. 2022-01-19
  10. US
    Drugs & medicalClass II

    DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600

    Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage

    FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →
  11. 2021-10-13
  12. US
    Drugs & medicalClass II

    DePuy Orthopaedics, Inc. recalls ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001

    Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery

    FDA · DeviceDePuy Orthopaedics, Inc.US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA,…Official notice →
All 8 DePuy Orthopaedics recalls →

Other drugs & medical recalls in the United States

  1. 2022-02-16
  2. US
    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

    FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, CT,…Official notice →
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    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 →
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    MEDLINE INDUSTRIES, LP - Northfield recalls CURAD REUSABLE GEL HOT/COLD PACK

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    Becton Dickinson & Co. recalls BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

    May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.

    FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of Armenia,…Official notice →
  6. US
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    GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist system, nuclear magnetic resonance imaging system.

    The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

    FDA · DeviceGE Healthcare, LLCDistribution was nationwide, including Puerto Rico and the Virgin Islands.…Official notice →
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    Microbiologics Inc recalls QC Sets and Panels, KWIK-STIK AST-GP (4 Strains) QC Set. KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control…

    Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used…

    FDA · DeviceMicrobiologics IncWorldwide Distribution. US nationwide including Puerto Rico and Guam,…Official notice →
See all drugs & medical recalls →