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ATTUNERecalls & reported problems across all models

Depuy (Ireland) · 1,475 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

13 open recalls name at least one ATTUNE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
41,078
Deaths reported
12
Injuries reported
19,411
Recalls
35

We found 1,475 models of ATTUNE by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 41,078 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2016 and Sep 30, 2026 — classified as 12 deaths, 19,411 injuries, 21,655 malfunctions.

The most frequently reported specific device problem is “Break” (14,241 reports).

35 FDA recall records name at least one of these models by its device identifier, 13 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Reports received per month, all models

Nov 2023: 407 reportsDec 2023: 355 reportsJan 2024: 449 reportsFeb 2024: 343 reportsMar 2024: 476 reportsApr 2024: 435 reportsMay 2024: 327 reportsJun 2024: 316 reportsJul 2024: 359 reportsAug 2024: 289 reportsSep 2024: 363 reportsOct 2024: 504 reportsNov 2024: 330 reportsDec 2024: 248 reportsJan 2025: 389 reportsFeb 2025: 268 reportsMar 2025: 292 reportsApr 2025: 366 reportsMay 2025: 400 reportsJun 2025: 358 reportsJul 2025: 443 reportsAug 2025: 367 reportsSep 2025: 256 reportsOct 2025: 382 reportsNov 2025: 556 reportsDec 2025: 435 reportsJan 2026: 422 reportsFeb 2026: 462 reportsMar 2026: 334 reportsApr 2026: 437 reportsMay 2026: 218 reportsJun 2026: 209 reportsJul 2026: 120 reportsAug 2026: 161 reportsSep 2026: 233 reportsOct 2026: 0 reports202420252026556
Last 36 months. The most recent month may be incomplete.

ATTUNE recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. May 19, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-2617-2026 · Root cause: Under Investigation by firm · names 40 of these models · Recall details · FDA record ↗

  2. May 19, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-2616-2026 · Root cause: Under Investigation by firm · names 22 of these models · Recall details · FDA record ↗

  3. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1993-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  4. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1992-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  5. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1991-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  6. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1990-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  7. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1989-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  8. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1988-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  9. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1987-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  10. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1986-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  11. Apr 3, 2026Open, Classified

    The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

    Z-1985-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  12. Feb 15, 2023Open, Classified

    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 the implant material properties.

    Z-1267-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

  13. Jun 29, 2022Open, Classified

    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 delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain

    Z-1419-2022 · Root cause: Process control · Recall details · FDA record ↗

  14. Jan 5, 2022Terminated

    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.

    Z-0632-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  15. Jan 5, 2022Terminated

    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.

    Z-0631-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

  16. Sep 9, 2021Terminated

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

    Z-0074-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

  17. Jul 1, 2021Terminated

    Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

    Z-2348-2021 · Root cause: Process change control · Recall details · FDA record ↗

  18. Feb 22, 2021Terminated

    Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

    Z-1316-2021 · Root cause: Packaging change control · names 5 of these models · Recall details · FDA record ↗

  19. Feb 22, 2021Terminated

    Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.

    Z-1314-2021 · Root cause: Packaging change control · names 7 of these models · Recall details · FDA record ↗

  20. Apr 16, 2018Terminated

    There may be burrs on the extraction hole threads.

    Z-1704-2018 · Root cause: Process control · Recall details · FDA record ↗

  21. Apr 16, 2018Terminated

    There may be burrs on the extraction hole threads.

    Z-1703-2018 · Root cause: Process control · Recall details · FDA record ↗

  22. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2146-2015 · Root cause: Device Design · names 8 of these models · Recall details · FDA record ↗

  23. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2145-2015 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

  24. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2144-2015 · Root cause: Device Design · Recall details · FDA record ↗

  25. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2143-2015 · Root cause: Device Design · names 9 of these models · Recall details · FDA record ↗

  26. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2142-2015 · Root cause: Device Design · names 10 of these models · Recall details · FDA record ↗

  27. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2141-2015 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗

  28. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2140-2015 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

  29. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2139-2015 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗

  30. Jun 12, 2015Terminated

    Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

    Z-2138-2015 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗

…and 5 older recalls, listed on each model's page.

Most reported ATTUNE problems

Device problems

  • Break14,241
  • Adverse Event Without Identified Device or Use Problem13,171
  • Loss of or Failure to Bond4,180
  • Crack1,783
  • Device-Device Incompatibility1,703
  • Naturally Worn991
  • Detachment of Device or Device Component917
  • Material Deformation827

Patient problems

  • No Clinical Signs, Symptoms or Conditions13,035
  • Pain7,403
  • No Code Available6,789
  • No Consequences Or Impact To Patient6,499
  • Unspecified Infection4,554
  • Insufficient Information2,554
  • Joint Laxity2,241
  • Adhesion(s)1,632

ATTUNE models

1,475 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

Recent ATTUNE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

Other Depuy (Ireland) products

All Depuy (Ireland) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page