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Recall Observatory FDA recall evidence

Device product

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308

Z-0894-2024

December 01, 2023

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 93687
Status
Ongoing
Classification
Class II
Quantity
1 units US; 146 units oUS
Official record key
device-enforcement:Z-0894-2024

Official wording

Reason: 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.

Code information: GTIN: 07613327033878 Lot Numbers: 2H58, 2J0W, 8H52, 64MJ, X0H9, 70E9

Distribution pattern: Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.