Scorpio 70-4107RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327028102), received between May 28, 2021 and May 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration Problem” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K974556); 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.

• InjuryMay 28, 2021Osseointegration Problem; Osseointegration Problem

  IN PERFORMING FOLLOW-UP FOR A PI THE REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2012 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: ASEPTIC LOOSENING RIGHT TOTAL KNEE REPLACEMENT. PATIENT WAS REVISED TO A TRIATHLON TS KNEE. AS PER SALES REP: "NOT SURE WHETHER IT WAS A SCORPIO OR A TRIATHLON."

  Patient problems: Inadequate Osseointegration

  MAUDE report 11903934 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974556. One submission often covers many models, so check the product and lot details in each record.

• 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-0466-2010 · Oct 2, 2009 · Terminated
  Scorpio CR Basic Femur with Posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee
• Z-0468-2010 · Oct 2, 2009 · Terminated
  Scorpio PS Basic Femur; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplast
• Z-0467-2010 · Oct 2, 2009 · Terminated
  Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total
• Z-0059-06 · Aug 11, 2005 · Terminated
  Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
• Z-0058-06 · Aug 11, 2005 · Terminated
  Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
• Z-1381-2008 · Feb 8, 2005 · Terminated
  Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stry