Compress® Device 178402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304259713), received between Apr 3, 2024 and Jun 7, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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-0371-2024 · 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.

• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THE PATIENT FELT A PAIN AROUND ONE MONTH POST REVISION. VISITED THE HCP FOR EXAMINATION EARLY MAY AND THE X-RAYS SHOWED SHORTENING BETWEEN THE ANCHOR PLUG AND SPINDLE AS IN THE PREVIOUS VISIT. NO REVISION HAS TAKEN PLACE AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 19491880 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THE COMPRESS INSTRUMENT MALFUNCTIONED, RESULTED IN DELAY OF APPROXIMATELY 30 MINUTES. THE DRILL BIT GOT STUCK IN THE TARGETER AND SEIZED. A SECOND ATTEMPT WAS MADE USING A SMALLER TARGETER AND THE SAME ISSUE HAPPENED A SECOND TIME BUT THE HCP STOPPED AND READJUSTED THE DEVICE AND THEN HAD TO FREEHAND THE TRANSVERSE PIN PLACEMENT. THE SURGICAL TECHNIQUE WAS FOLLOWED. THE DRILL BITS DID FRACTURE BUT ALL PIECES WERE RECOVERED PRIOR TO PROCEEDING WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SATISFACTORILY. THERE WAS NO PATIENT HARM, JUST THE 30 MIN DELAY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19036882 ↗

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-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-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-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-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