Compress® Device 178554Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304461703), received between Mar 24, 2021 and Apr 12, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

20 other recalls cover devices cleared under the same FDA submission (K062998); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 9, 2023Open, Classified

   Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery

   Z-0379-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO AN UNKNOWN FAILURE OF THE COMPRESS PROSTHESIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19097978 ↗
• InjuryApr 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION DUE TO AN UNKNOWN FAILURE OF THE COMPRESS PROSTHESIS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19097921 ↗
• InjuryJun 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT FELL, WHICH RESULTED IN PAIN AND AN INABILITY TO STAND UP. EXAMINATION REVEALED THAT THE ROOT PART OF THE ANCHOR PLUG IMPLANT HAD FRACTURED. SUBSEQUENTLY, A REVISION SURGERY WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Fall; Pain

  MAUDE report 14829524 ↗
• InjuryDec 31, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 13124981 ↗
• InjuryMar 24, 2021Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cancer; Failure of Implant

  MAUDE report 11562603 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062998. One submission often covers many models, so check the product and lot details in each record.

• Z-0388-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178570
• Z-0386-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178566
• Z-0371-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
• Z-0376-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178412
• Z-0387-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178568
• Z-0370-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
• Z-0384-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178564
• Z-0378-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178552
• Z-0385-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178565
• Z-0383-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178562
• Z-0382-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178560
• Z-0373-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178406
• Z-0381-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Item Number: 178558
• Z-0374-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178408
• Z-0375-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410

…and 5 more.