Scorpio 71-4509LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327028393), received between Aug 18, 2021 and Aug 18, 2021 — classified as 1 injury.

13 other recalls cover devices cleared under the same FDA submission (K962152); 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.

• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY (B)(6) (VIA THE PATIENT) THAT AN INCIDENT REPORT HAD OCCURRED. IT WAS REPORTED THAT THE PATIENT ALLEGED "METALLOSIS WAS CONFIRMED VIA LABS IN (B)(6) 2020". IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A NUMBER OF HEALTH CONCERNS.

  Patient problems: Foreign Body Reaction

  MAUDE report 12335161 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962152. One submission often covers many models, so check the product and lot details in each record.

• Z-0892-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
• Z-0887-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510
• Z-0888-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710
• Z-0886-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
• Z-0890-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
• Z-0889-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
• Z-0891-2024 · Dec 1, 2023 · Open, Classified
  SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
• 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-0469-2010 · Oct 2, 2009 · Terminated
  Scorpio PS Femur Waffle Posts with LfIt; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total
• Z-0795-2010 · Jul 30, 2007 · Terminated
  Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to repl
• Z-1814-2008 · Nov 8, 2005 · Terminated
  Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalo
• Z-2079-2008 · Mar 17, 2005 · Terminated
  Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Com
• Z-1382-2008 · Feb 8, 2005 · Terminated
  Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; St