Compress® Device 178406Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304259744), received between Feb 8, 2021 and Dec 18, 2023 — classified as 1 injury, 2 malfunctions.

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

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

6 other recalls cover devices cleared under the same FDA submission (K031804, K043547); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-0373-2024 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY. DURING THE PROCEDURE, THE ANCHOR PLUG FRACTURED DURING ASSEMBLY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345196 ↗
• MalfunctionAug 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE ANCHOR PLUG BROKE WHEN THREADING ON THE NUT. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439895 ↗
• InjuryFeb 8, 2021Fracture; Fracture

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

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 11294194 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031804, K043547. One submission often covers many models, so check the product and lot details in each record.

• Z-1526-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086. A non-powered, orthopedic manual surgical instru
• Z-1527-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087. A non-powered, orthopedic manual surgical instrum
• Z-1529-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic manual surgical instr
• Z-1528-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical inst
• Z-1530-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124. A non-powered, orthopedic manual surgic
• Z-1531-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical