Simplify® Cervical Artificial Disc (REF SM-4L)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843285100016), received between Jan 21, 2026 and Jan 21, 2026 — classified as 1 malfunction.

1 other recall cover devices cleared under the same FDA submission (P200022); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THERE WERE 2 DISCS EXPLANTED FROM THE CERVICAL SPINE. THE PATIENT HAD THESE PLACED THREE YEARS AGO BUT A COUPLE MONTHS AGO, FELL OFF OF A HORSE CAUSING INCREASED NECK PAIN. THIS IS THE REASON THEY DECIDED TO DO A FUSION AND REMOVE THE ARTIFICIAL DISCS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133580 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P200022. One submission often covers many models, so check the product and lot details in each record.

• Z-1453-2022 · Jun 20, 2022 · Open, Classified
  Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/MD-5; Simplify Disc Size 2, Ht