Osteonics Scorpio Total Knee Universal Dome Patellar Component;osteonics Scorpio Total Knee Recessed Patellar Component

• 6 recalls, same reason

  • Ongoing Z-0895-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0894-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0896-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0893-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0897-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0900-2024 FDA Class II ·initiated 1 Dec 2023

  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.

510(k) Number

K972967 ↗

FDA Product Code

JWH

Models / Variants

Osteonics Scorpio Total Knee Universal Dome Patellar Component

osteonics Scorpio Total Knee Recessed Patellar Component

Device Class

Class II

Regulation

21 CFR Part 888.3560

Advisory Committee

Orthopedic

FDA Decision

SN

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See all devices from Osteonics Corp. →