EIT CIF Inserter CET30101Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04260397080214), received between Sep 8, 2020 and Feb 10, 2025 — classified as 5 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K170503); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED INSTRUMENTS WERE RUSTY, HAD BROKEN THREADS AND BROKEN TIPS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343462 ↗
• MalfunctionFeb 10, 2025Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTED INSTRUMENTS WERE RUSTY, HAD BROKEN THREADS AND BROKEN TIPS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343457 ↗
• MalfunctionSep 28, 2023Break; Break

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE TENSION ARM SNAPPED AND FELL OFF AS THE SURGEON WAS ABOUT TO IMPLANT THE CAGE. THE LOCKING NUT HELD THE INSERTER HANDLES CLOSED, SO THE EVENT DID NOT HAVE AN IMPACT ON THE OPERATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR AN INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17837893 ↗
• MalfunctionMay 7, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED DURING PREP (PRE-OPERATIVELY) THAT AN INSERTER WAS NO LONGER ABLE TO CONNECT TO IMPLANT TO INSERT. THE DIAL DOES NOT LOCK. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR PC- (B)(4). THIS REPORT IS FOR AN INSERTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316103 ↗
• MalfunctionSep 8, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE CONDUIT CERVICAL IMPLANT INSERTER WAS BROKEN. THE SPRING THAT ALLOWS THE INSERTER TO OPEN WAS DAMAGED. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED AND REMOVED. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) INSERTER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10501742 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170503. One submission often covers many models, so check the product and lot details in each record.

• Z-1324-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD
• Z-1323-2022 · May 20, 2022 · Open, Classified
  EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DD