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Recall Observatory FDA recall evidence

Device product

SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508

Z-0895-2024

December 01, 2023

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 93687
Status
Ongoing
Classification
Class II
Quantity
137 units US; 326 units OUS
Official record key
device-enforcement:Z-0895-2024

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: 07613327033885 Lot Numbers: EPXH, DYAE, XVK2, PVP9, LJ0K, 12R3, N8P6, T355, 8HDN, A3EV, 5LKW, R04Y, RKT1,D06K, 01JR, 3PA4, 0AYL, W424, 53T1, Y7X2,

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.