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U.S. Department of Health and Human Services

Class 2 Device Recall Conformis iTotal Identity Posterior Stabilised (PS) Knee

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  Class 2 Device Recall Conformis iTotal Identity Posterior Stabilised (PS) Knee see related information
Date Initiated by Firm February 22, 2022
Create Date April 08, 2022
Recall Status1 Completed
Recall Number Z-0899-2022
Recall Event ID 89903
510(K)Number K210809  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101
Code Information Serial Number: 0496242 UDI: M572TPS3011113011
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr Ste 3
Billerica MA 01821-4154
For Additional Information Contact Kara Johnson
781-345-9001
Manufacturer Reason
for Recall		 Incorrect tibial base plate implant packaged in kit
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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.
Quantity in Commerce 1 unit
Distribution MS
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Conformis, Inc.
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