Scorpio 82-2-0908Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540400734), received between Jun 15, 2020 and Jun 15, 2020 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 1, 2023Open, Classified

   Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

   Z-0899-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PARTICIPATES IN THE SCORPIO NRG STUDY K-S-002. THE PATIENT WAS BELIEVED TO WITHDRAW STUDY PARTICIPATION ON (B)(6) 2011 AND WAS TERMINATED FROM THE STUDY. ACTUALLY THE PATIENT RETURNED BACK TO CLINIC FOR PROSTHESIS REMOVAL DUE TO INFECTION (STAPH.AUREUS) AND REPLACEMENT/SPACER AND REPLACEMENT ON (B)(6) 2012

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10153614 ↗

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-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-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-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