Scorpio 81-4403L

• FDA 510(k) K030978 decided 20 Nov 2003 Active
• FDA GUDID UDI-DI 07613327029444 listed 24 Sep 2015 Listed

• • Ongoing Z-0899-2024 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.

• 8 recalls, same reason

  • Terminated Z-0470-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0472-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0471-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0477-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0475-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0474-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0473-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0476-2010 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-1141-2010 FDA Unclassified (pre-2012) ·initiated 20 Aug 2007

  A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

1. 2 Oct 2009 Recall initiated FDA recalls Z-0472-2010
2. 2 Oct 2009 Recall initiated FDA recalls Z-0471-2010
3. 2 Oct 2009 Recall initiated FDA recalls Z-0477-2010
4. 2 Oct 2009 Recall initiated FDA recalls Z-0475-2010
5. 2 Oct 2009 Recall initiated FDA recalls Z-0474-2010
6. 2 Oct 2009 Recall initiated FDA recalls Z-0473-2010
7. 2 Oct 2009 Recall initiated FDA recalls Z-0476-2010
8. 15 Aug 2014 Recall initiated FDA recalls Z-1634-2015
9. 24 Sep 2015 Listed FDA GUDID 07613327029444
10. 1 Dec 2023 Recall initiated FDA recalls Z-0899-2024

3 earlier events are in the sections above.

Trade name

Scorpio

Generic name

Uncoated knee femur prosthesis, metallic

Model / Ref / Catalog

81-4403L

Primary DI / UDI-DI

07613327029444

510(k) Number

K030978 ↗

FDA product code

JWH

GMDN term

Uncoated knee femur prosthesis, metallic

Device class

Class II

Regulation number

888.3560

GUDID distribution status

In Commercial Distribution

Category: Uncoated knee femur prosthesis, metallic

Other devices filed under Uncoated knee femur prosthesis, metallic.

• GMK Primary Total Knee System 02.07.2215L by Medacta International SA
• GMK Sphere Total Knee System 02.12.0003L by Medacta International SA
• PHYSICA CR Left Femoral Comp. 6513.09.580 by Limacorporate
• APEX Revision Knee KP-0415L by OMNIlife science, Inc.
• APEX PS Knee KP-0020L by OMNIlife science, Inc.
• PHYSICA PS Left Femoral Comp. 6515.09.540 by Limacorporate

• Exeter® Contemporary™

  Class III

  CE/MDR

• Mrh

  Class IIa

  CE/MDR

• Exeter

  Class IIa

  CE/MDR

• Instrument

  Class I

  CE/MDR

See all devices from Howmedica Osteonics Corp. →