Modular Arthrodesis Nail CP260600Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304082977), received between Oct 28, 2021 and Jun 12, 2024 — classified as 4 injuries, 2 malfunctions.

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

2 other recalls 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19518876 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518865 ↗
• InjuryNov 16, 2022Fracture; Unstable; Detachment of Device or Device Component; Migration; Fracture; Unstable; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY. APPROXIMATELY THREE YEARS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY AND IT WAS DETERMINED THAT THE LOCKING COLLAR DISASSOCIATED. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY WHERE IT WAS REVEALED THAT THE SMALL LOCKING SCREWS OF THE COLLAR HAD BACKED OUT AND ONE LOCKING SCREW HAD FRACTURED. THE REVISION SURGERY WAS COMPLETED WITHOUT COMPLICATION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 15803961 ↗
• InjuryFeb 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT WAS REVISED 3 MONTHS POST REVISION DUE TO LOOSENING. NO ADDITIONAL INFORMATION AVAILABLE. PREVIOUSLY, THE PATIENT UNDERWENT A KNEE REPLACEMENT PROCEDURE. THE PATIENT SPUN INTO EXTERNAL ROTATION AND WAS REVISED APPROXIMATELY 5 MONTHS POST IMPLANTATION. IT WAS ALSO NOTED- HCP USED A DUAL COMPRESS MOD A INTERCALARY SEGMENT AS A MID SHAFT FEMUR INTERCALARY. IT WAS KNOWN TO BE OFF LABEL.

  Patient problems: Failure of Implant

  MAUDE report 13601094 ↗
• InjuryFeb 11, 2022Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  IT WAS REPORTED THE PATIENT UNDERWENT A KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT SPUN INTO EXTERNAL ROTATION AND WAS REVISED APPROXIMATELY 5 MONTHS POST IMPLANTATION. IT WAS ALSO NOTED- HCP USED A DUAL COMPRESS MOD A INTERCALARY SEGMENT AS A MID SHAFT FEMUR INTERCALARY. IT WAS KNOWN TO BE OFF LABEL. NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 13515208 ↗
• MalfunctionOct 28, 2021Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712076 ↗

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-1036-2023 · Nov 29, 2022 · Open, Classified
  OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrode
• 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