Compress® Device 178400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304259690), received between Mar 23, 2022 and May 23, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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. 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-0370-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2024Fracture; Difficult to Insert; Fracture; Difficult to Insert

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382392 ↗
• InjuryMar 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING DRILLING OF THE TRANSVERSE PIN, THE TIP PART BROKE INTO THE PATIENT AND THE BROKEN PIECE REMAINS IN THE PATIENT BODY. THE PATIENT HAS NOT EXPERIENCED ANY COMPLICATIONS SINCE THE INITIAL SURGERY. NO REVISION SURGERY IS PLANNED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13869614 ↗

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-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-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-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
• 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