iTotal Identity Posterior Stabilised (PS) Knee Replacement (Conformis) – incorrect tibial base pl...
Incorrect tibial base plate can lead to surgical complications during implantation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Brand
Conformis, Inc.
Lot Codes / Batch Numbers
Serial Number: 0496242 UDI: M572TPS3011113011
Products Sold
Serial Number: 0496242 UDI: M572TPS3011113011
Conformis, Inc. is recalling iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 due to Incorrect tibial base plate implant packaged in kit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect tibial base plate implant packaged in kit
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MS
Page updated: Jan 10, 2026