DePuy Orthopaedics recalls

8 official recalls and safety alerts involving DePuy Orthopaedics since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with DePuy Orthopaedics or the relevant agency.

  1. 2024-04-10
  2. US
    Drugs & medicalClass II

    DePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.

    Product incorrectly labelled.

    FDA · DeviceDePuy Orthopaedics, Inc.Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the…Official notice →
  3. 2023-03-29
  4. US
    Drugs & medicalClass II

    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 →
  5. 2022-07-27
  6. US
    Drugs & medicalClass II

    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 →
  7. 2022-07-20
  8. 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 →
  9. 2022-05-11
  10. 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 →
  11. 2022-02-16
  12. 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 →
  13. 2022-01-19
  14. 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 →
  15. 2021-10-13
  16. 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 →