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U.S. Department of Health and Human Services

Class 2 Device Recall Identity Imprint PS Tibial Tray

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  Class 2 Device Recall Identity Imprint PS Tibial Tray see related information
Date Initiated by Firm March 11, 2024
Date Posted April 17, 2024
Recall Status1 Open3, Classified
Recall Number Z-1591-2024
Recall Event ID 94288
510(K)Number K210191  K231233  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Identity Imprint PS Tibial Tray Size 4: Lot 540287
Code Information Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr # 400
Billerica MA 01821-4154
For Additional Information Contact Karen Roberts
603-490-4184
Manufacturer Reason
for Recall		 Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
FDA Determined
Cause 2		 Process design
Action On March 22, 2024 customers were sent URGENT MEDICAL DEVICE FIELD ACTION letters via email. Customers were provided the following instructions: Conformis is seeking the return of the devices in boxes marked with Lot 508287 or Lot 540827. This is the only lot that was distributed. Our records indicate you are the recipient of one of the affected Lot. If you have not already, please return the device using the provided FEDEX label. Additionally, return page 2 of this letter to acknowledge receipt of this notification. Please read, complete, and sign page 2 of this letter. If you have any questions please contact myself or another Conformis representative. If you have an urgent question, please call customer service 781 345 9001.
Quantity in Commerce 3 units
Distribution US Nationwide distribution in the states of FL, KS and NH.
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Conformis Inc.
510(K)s with Product Code = JWH and Original Applicant = Conformis, Inc.
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