Scorpio 82-2-0708Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540400666), received between Apr 30, 2020 and Apr 30, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY STRYKER SALES REP THAT THE DOCTOR HAD EVALUATED BEFORE STARTING THE CASE,WHICH WAS FULL REVISION KNEE,BUT WHEN OPENING THE WOUND AND FOUND THAT FEMUR AND INSERT BECAME LOOSE AND THE FUNCTION KNEE WAS ABNORMAL, BUT TIAL STILL HAD GOOD QUALITY,SO CHANGED FEMUR AND INSERT INSTEAD. ON 30 MAR 2020, STRYKER SALES REP WAS MADE AWARE OF THE SCHEDULED REVISION SURGERY WILL BE CARRY OUT ON (B)(6) 2020.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10013666 ↗

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