Scorpio 82-3-0708

• FDA 510(k) K261898 decided 6 Aug 2026 Active· +2 more in the status table
• FDA GUDID UDI-DI 04546540364418 listed 24 Sep 2015 Listed

• 2 recalls, same reason

  • Ongoing Z-3206-2026 FDA Class II ·initiated 30 Jul 2026 ·on shared 510(k) K243817
  • Ongoing Z-3197-2026 FDA Class II ·initiated 30 Jul 2026

  Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

• • 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-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
  • Terminated Z-0470-2010 FDA Unclassified (pre-2012) ·initiated 2 Oct 2009
  • Terminated Z-0472-2010 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.

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

1. 2 Oct 2009 Recall initiated FDA recalls Z-0476-2010
2. 2 Oct 2009 Recall initiated FDA recalls Z-0470-2010
3. 2 Oct 2009 Recall initiated FDA recalls Z-0472-2010
4. 15 Aug 2014 Recall initiated FDA recalls Z-1634-2015
5. 24 Sep 2015 Listed FDA GUDID 04546540364418
6. 1 Dec 2023 Recall initiated FDA recalls Z-0899-2024
7. 6 Feb 2025 Cleared FDA 510(k) K243817
8. 30 Jul 2026 Recall initiated FDA recalls Z-3206-2026
9. 30 Jul 2026 Recall initiated FDA recalls Z-3197-2026
10. 6 Aug 2026 Cleared FDA 510(k) K261898

7 earlier events are in the sections above.

Trade name

Scorpio

Generic name

Tibial insert

Model / Ref / Catalog

82-3-0708

Primary DI / UDI-DI

04546540364418

510(k) Number

K030978 ↗

K243817 ↗

K261898 ↗

FDA product code

JWH

GMDN term

Tibial insert

Device class

Class II

Regulation number

888.3560

GUDID distribution status

In Commercial Distribution

Category: Tibial insert

Other devices filed under Tibial insert.

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• PHYSICA LMC 6537.50.316 by Limacorporate
• GMK Sphere Total Knee System 02.12.E0211FL by Medacta International SA
• APEX Knee System EC-35052 by OMNIlife science, Inc.
• APEX Knee System EP-22613 by OMNIlife science, Inc.

• 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. →