Cortoss 2110-0039Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00808232001372), received between Sep 14, 2016 and Feb 6, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

4 other recalls cover devices cleared under the same FDA submission (K080108); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT THE CONNECTOR WAS BROKEN WHILE TIGHTENING THE INTERCONNECTION DURING ROD PLACEMENT STAGE. A SPARE IMPLANT WAS USED TO COMPLETE THE SURGERY. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7244231 ↗
• MalfunctionNov 21, 2017Break; Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT; LOCKING SCREW BROKE IN PLATE. UPDATE 10/31/2017: EVENT OCCURED DURING SURGERY.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7049722 ↗
• MalfunctionMay 17, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT; SALES REP STATES THE DELIVERY GUN TRIGGER BROKE DURING INJECTION.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6572679 ↗
• MalfunctionSep 14, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE DELIVERY GUN BROKE. THE PLUGGER BROKE DURING THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5951241 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080108. One submission often covers many models, so check the product and lot details in each record.

• Z-2101-2021 · May 18, 2021 · Terminated
  Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
• Z-2100-2021 · May 18, 2021 · Terminated
  Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
• Z-1900-2020 · Apr 1, 2020 · Terminated
  Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
• Z-3188-2011 · Mar 31, 2011 · Terminated
  Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material