Scorpio 82-3-0310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540364289), received between Jan 12, 2024 and Mar 20, 2024 — classified as 2 injuries.

13 other recalls cover devices cleared under the same FDA submission (K030978, K243817); 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.

• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN INFECTION. AND UNDERWENT A BILATERAL REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 18941601 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALE REP THAT PATIENT NEEDS A REVISION SURGERY DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18500409 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030978, K243817. One submission often covers many models, so check the product and lot details in each record.

• Z-3206-2026 · Jul 30, 2026 · Open, Classified
  SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyet
• Z-3197-2026 · Jul 30, 2026 · Open, Classified
  ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PAT
• Z-0899-2024 · Dec 1, 2023 · Open, Classified
  Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
• Z-1634-2015 · Aug 15, 2014 · Terminated
  Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of
• Z-0473-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, #3 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilize
• Z-0476-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, # 7 left/right; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is
• Z-0474-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral. # 4 left/right; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is
• Z-0472-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Cruciate Retaining Femoral, Left # 8; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized
• Z-0475-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, # 5 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07340. The Scorpio Femoral Components are a knee component that is utiliz
• Z-0477-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Posterior Stabilized Femoral, #9 left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilize
• Z-0471-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Cruciate Retaining Femoral, Right # 7; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilize
• Z-0470-2010 · Oct 2, 2009 · Terminated
  Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is ut
• Z-1141-2010 · Aug 20, 2007 · Terminated
  Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ