Scorpio 82-2-0710Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540400673), received between Mar 20, 2019 and Aug 29, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K042343, 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.

• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION FOR SCORPIO NRG POLY CHANGE AND PATELLA RESURFACING.

  Patient problems: Injury

  MAUDE report 8945148 ↗
• MalfunctionMar 20, 2019Device Difficult to Setup or Prepare; Device Markings/Labelling Problem; Device Difficult to Setup or Prepare; Device Markings/Labelling Problem

  INSERT COULD NOT BE INSERTED. THE INSERT WAS NOT ENGRAVED, CATALOG# AND SN# WERE MISSING ON THE ITEM. TO COMPLETE THE SURGERY SUCCESSFULLY A12MM INSERT WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436134 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042343, 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-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