OSS™ Orthopedic Salvage System 161079Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304462144), received between Sep 12, 2023 and Sep 12, 2023 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K052685, K123501); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 11 MONTHS POST IMPLANTATION DUE TO A DISTAL FEMUR FRACTURE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 17732653 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052685, K123501. One submission often covers many models, so check the product and lot details in each record.

• Z-2213-2008 · Nov 7, 2007 · Terminated
  OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043. Implant is part of a system used
• Z-2214-2008 · Nov 7, 2007 · Terminated
  Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044. Implant is part of a system used to repl