Conformis, Inc. Recall 89903
Description: iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Conformis, Inc. Recall 89903 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0899-2022 |
Event ID | 89903 |
Event Description | iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 |
Product Type | Devices |
Distribution | MS |
Quantity | 1 unit |
Recall Reason | Incorrect tibial base plate implant packaged in kit |
Device Classification | 20220420 |
Device Code Info | Serial Number: 0496242 UDI: M572TPS3011113011 |
Center Classification Date | 20220408 |
Recall Initiation Date | 20220222 |
Recalling Firm | Conformis, Inc. |
Initial Notification | Other |
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