Osteonics Scorpio Posteriorly Stabilized Total Knee System

• 7 recalls, same reason

  • Ongoing Z-0886-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0892-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0887-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0891-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0890-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0888-2024 FDA Class II ·initiated 1 Dec 2023
  • Ongoing Z-0889-2024 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.

• • Terminated Z-1634-2015 FDA Class II ·initiated 15 Aug 2014

  The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

• • Terminated Z-0469-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009

  It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

• • Terminated Z-0795-2010 FDA Unclassified (pre-2012) ·initiated 30 Jul 2007

  Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.

• • Terminated Z-1814-2008 FDA Unclassified (pre-2012) ·initiated 8 Nov 2005 ·on shared 510(k) K962152

  Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.

• • Terminated Z-2079-2008 FDA Unclassified (pre-2012) ·initiated 17 Mar 2005

  Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.

• • Terminated Z-1382-2008 FDA Unclassified (pre-2012) ·initiated 8 Feb 2005

  Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K962152 ↗

FDA Product Code

JWH

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. →