Compress® Device 178556Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304461635), received between Jul 26, 2022 and Feb 13, 2025 — 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-0380-2024 · 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.

• InjuryFeb 13, 2025Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 21378853 ↗
• InjuryMay 26, 2023Fracture; Fracture

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 17009989 ↗
• MalfunctionJan 17, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186242 ↗
• InjuryJul 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT A SURGERY WAS PERFORMED FOR A PROXIMAL TIBIA TUMOR WITH ORTHOPEDIC SALVAGE SYSTEM IMPLANTS. POSTOPERATIVELY, THE SURGEON FOUND THAT THE ANCHOR PLUG BROKE. THERE WAS BONE FORMATION SEEN ON THE SIDE VIEW AND PARTIALLY SEEN ON THE FRONT VIEW OF X-RAYS. THE PATIENT WAS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s); Failure of Implant; Pain

  MAUDE report 15105781 ↗

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-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-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-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-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-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-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
• 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-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-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-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-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-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-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

…and 5 more.