Modular Arthrodesis Nail CP260602Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304082991), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 malfunction.

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

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

1 other recall cover devices cleared under the same FDA submission (K042409); 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. Nov 29, 2022Open, Classified

   Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

   Z-1036-2023 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2020Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A REVISION OF A LEFT KNEE OSS SYSTEM DUE TO A BROKEN JUNCTION/CONNECTOR COMPONENT, THE SURGEON STATED THAT THE MORRIS TAPER COULD NOT BE BROKEN FROM THE FEMORAL STEM DESPITE MULTIPLE ATTEMPTS AND DIFFERENT INSTRUMENTS. THE SURGERY HAD TO BE MODIFIED TO CUT THE SEGMENTS APART, EXTENDING SURGICAL TIME BY AN HOUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580992 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042409. One submission often covers many models, so check the product and lot details in each record.

• Z-1522-2018 · Apr 3, 2018 · Terminated
  Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmental defects of long bone, including mids