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Howmedica Osteonics Corp. Recall 93687

Description: SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110

Howmedica Osteonics Corp. Recall 93687 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0893-2024
Event ID93687
Event DescriptionSCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110
Product TypeDevices
DistributionNationwide 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.
Quantity107 units US; 176 units OUS
Recall ReasonProduct 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.
Device Classification20240207
Device Code InfoGTIN: 07613327033861 Lot Numbers: XEA7, 8P83, 690Y, MRM3, 67D4, 4902, YNP7, 3AYN, AYHM, W3MD, 76KN, K4P9, 792H, 43T8, MW40
Center Classification Date20240131
Recall Initiation Date20231201
Recalling FirmHowmedica Osteonics Corp.
Initial Notification Letter
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