EIT PLIF Hammer PET60251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260397088081), received between Feb 7, 2023 and Apr 22, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

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 16, 2026.

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.

• MalfunctionApr 22, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT ON FEBRUARY 7, 2024, THE CUSTOMER REPORTED THAT THE LSY EXPEDIUM VIPER LOANER ORTHOKIT SET CAME WITH ONE OF THE EJECTORS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE LASER WELD NEAR THE INTERFACE AND THE ROD WAS BROKEN; FRAGMENTS STILL ATTACHED. THIS REPORT IS FOR A SLAP-HAMMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153181 ↗
• MalfunctionFeb 7, 2023

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315700 ↗

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