Simplify 5709935P2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00195377105509), received between May 1, 2026 and May 1, 2026 — classified as 3 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  A SIMPLIFY DISC REMOVAL OCCURRED ON (B)(6) 2026. THE SURGEON REPORTED CONCERNS OF OSTEOLYSIS.

  Patient problems: Osteolysis

  MAUDE report 25058434 ↗
• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  A 60-YEAR-OLD FEMALE PATIENT HAD OSTEOLYSIS PRESENT SO CONVERTED TO 3 LEVEL FUSION WITH PLATE.

  Patient problems: Osteolysis

  MAUDE report 25058208 ↗
• MalfunctionMay 1, 2026Adverse Event Without Identified Device or Use Problem

  A SIMPLIFY DISC REMOVAL DUE TO OSTEOLYSIS WAS REPORTED. CONVERTED TO FUSION.

  Patient problems: Osteolysis

  MAUDE report 25057555 ↗

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