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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) Kneesee related information
Date Initiated by FirmFebruary 22, 2022
Create DateApril 08, 2022
Recall Status1 Completed
Recall NumberZ-0899-2022
Recall Event ID 89903
510(K)NumberK210809 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductiTotal 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 ContactKara Johnson
781-345-9001
Manufacturer Reason
for Recall		Incorrect tibial base plate implant packaged in kit
FDA Determined
Cause 2		Nonconforming Material/Component
ActionConformis 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 Commerce1 unit
DistributionMS
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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