Compress® Device 178558Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304461673), received between Apr 29, 2021 and Mar 26, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (4 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-0381-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Fracture

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO IMPLANT FRACTURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24698768 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020787 ↗
• InjuryJul 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 1 MONTH POST IMPLANTATION S THE PATIENT FELL AND BROKE THE ANCHOR PLUG. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Fall; Pain

  MAUDE report 15016257 ↗
• InjuryApr 29, 2021Fracture; Fracture

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY 18 MONTHS POST IMPLANTATION DUE TO A BROKEN COMPRESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11750690 ↗

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-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
• 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-0372-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
• 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-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-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-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-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-0377-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
• 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-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-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-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-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-0379-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554

…and 5 more.