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Howmedica Osteonics Corp. Recall 93687

Description: SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026

Howmedica Osteonics Corp. Recall 93687 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0869-2024
Event ID93687
Event DescriptionSCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
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.
Quantity94 units US; 131 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: 07613327033779 Lot Numbers: PVDY TEN1 AMN1 V644 MHHE 4T1K V355 55LK JR6R
Center Classification Date20240131
Recall Initiation Date20231201
Recalling FirmHowmedica Osteonics Corp.
Initial Notification Letter
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