Compress® Device 178552Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00880304461659), received between Jun 30, 2021 and Sep 9, 2025 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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-0378-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Migration; Migration

  IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PAIN OVER A SPAN OF THE LAST YEAR. THE SURGEON BELIEVED THE EXPANDABLE COMPONENT WAS EXPANDING ON ITS OWN, WITHOUT THE REQUIRED SURGERY TO EXPAND IT. THE PATIENT FELT A POP AND COULD NOT BEAR WEAR. THE PATIENT WAS THEN REVISED APPROXIMATELY 3 YEARS POST IMPLANTATION DUE TO A BROKEN ANCHOR PLUG AND THE SPINDLE LOST BONE IN-GROWTH AT THE BONE INTERFACE AND WAS NO LONGER FIXED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 23010320 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FLEXION CONTRACTURE AND STIFFNESS APPROXIMATELY TWENTY-TWO (22) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Contracture; Loss of Range of Motion

  MAUDE report 21036223 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FLEXION CONTRACTURE AND STIFFNESS APPROXIMATELY TWENTY-TWO (22) MONTHS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Joint Contracture; Loss of Range of Motion

  MAUDE report 21036166 ↗
• InjuryAug 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY SIXTEEN (16) MONTHS POST-IMPLANTATION DUE TO FRACTURE OF THE ANCHOR PLUG. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 19960275 ↗
• MalfunctionJan 22, 2024Fracture; Difficult to Insert; Physical Resistance/Sticking; Fracture; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE TRYING TO ALIGN THE DRILL GUIDE AND THE ANCHOR PLUG DURING SURGERY, THE DRILL BIT SEIZED WITH THE GUIDE AND THE DRILL BIT FRACTURED. STAFF WERE UNSURE IF THE GUIDE OR THE ANCHOR PLUG WAS NOT LINING UP EVENLY WITH THE DRILL BITS THROUGH THE BOOM AND ANCHOR IN-SITU. THE SURGERY WAS NOT COMPLETED WITH ANY SECOND DEVICES. THERE WERE NO FOREIGN BODIES RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553841 ↗
• MalfunctionJan 12, 2023Fracture; Fracture

  IT WAS REPORTED THE TRACTION BAR OF COMPRESS ANCHOR PLUG FRACTURED WHILE PLACING THE COMPRESSION NUT. NO PIECES FELL INTO THE PATIENT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16150098 ↗
• MalfunctionDec 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL RIGHT KNEE PROCEDURE, AN ANCHOR PLUG IMPLANT FRACTURED DURING IMPLANTATION. THERE WAS A SURGICAL DELAY OF FORTY-FIVE (45) MINUTES WHILE THE FRACTURED COMPONENT AND THE ASSOCIATED CONNECTIONS WERE REMOVED AND REPLACEMENT DEVICES WERE IMPLANTED. THERE WAS NO PATIENT IMPACT REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075215 ↗
• MalfunctionAug 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A RIGHT KNEE PROCEDURE, AN ANCHOR PLUG IMPLANT FRACTURED DURING IMPLANTATION. THERE WAS A SURGICAL DELAY OF FORTY MINUTES WHILE THE FRACTURED COMPONENT AND THE ASSOCIATED CONNECTIONS WERE REMOVED AND REPLACEMENT DEVICES WERE IMPLANTED. THERE WAS NO PATIENT IMPACT REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191150 ↗
• InjuryJun 30, 2021Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED TO BE REVISED DUE TO A FAILED COMPRESS. THE PATIENT THEN UNDERWENT A REVISION SURGERY ONE WEEK AFTER INITIAL IMPLANTATION. THE TRACTION BAR APPEARS TO HAVE BENT. THE SURGEON STATED HE IS UNSURE IF THE FRACTURED BONE WAS AN EFFECT OR A CAUSE OF THE FAILED COMPRESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 12094379 ↗

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-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-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-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-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-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
• Z-0380-2024 · Oct 9, 2023 · Open, Classified
  Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
• 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-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-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-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-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.