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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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