Howmedica Osteonics Corp. Recall 93687
Description: DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
Howmedica Osteonics Corp. Recall 93687 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0917-2024 |
Event ID | 93687 |
Event Description | DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911 |
Product Type | Devices |
Distribution | 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. |
Recall 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. |
Device Classification | 20240207 |
Device Code Info | GTIN:04546540318299 Lot Numbers: 56000801, 57491601 |
Center Classification Date | 20240131 |
Recall Initiation Date | 20231201 |
Recalling Firm | Howmedica Osteonics Corp. |
Initial Notification | Letter |
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