iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
- Company
- Conformis, Inc.
- Recall Initiated
- February 22, 2022
- Recall Number
- Z-0899-2022
- Quantity
- 1 unit
- Firm Location
- Billerica, MA
Reason for Recall
Incorrect tibial base plate implant packaged in kit
Distribution
MS
Lot / Code Info
Serial Number: 0496242 UDI: M572TPS3011113011
Root Cause
Nonconforming Material/Component
Action Taken
Conformis issued Notifications to Conformis sales representative via phone conversation. The sales representative spoke with the respective surgeons on 2/22/22 to retrieve the product. No phone script was saved.
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Identity Imprint PS Tibial Tray Size 4: Lot 540287
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