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U.S. Department of Health and Human Services

Class 2 Device Recall Conformis iTotal Hip Replacement System

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  Class 2 Device Recall Conformis iTotal Hip Replacement System see related information
Date Initiated by Firm September 21, 2020
Create Date November 20, 2020
Recall Status1 Open3, Classified
Recall Number Z-0475-2021
Recall Event ID 86615
510(K)Number K192198  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product iTotal Hip Replacement System, Model number HAA-050-D020-020102

The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation.
Code Information Serial numbers 0469255, 0469255
Recalling Firm/
Manufacturer
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact Kara Johnson
781-832-5402
Manufacturer Reason
for Recall
Incorrect hip components were provided in kits.
FDA Determined
Cause 2
Process control
Action The firm received complaints regarding the mix-up of serial numbers on September 11, 2020, and September 21, 2020, from a sales representative who reported that the incorrect iView bearing serial number 0469255 was provided in the kit for serial number 0469225, and that the incorrect iJigs bearing serial number 0469225 were provided in the kit for serial number 0469255. One of the kits was used, while the other was returned to the firm. The firm reported that the co-mingle only involved these two kits. Upon notification of the issue, the firm implemented a planned deviation to verify that there were no other occurrences of the issue. All components were found to be associated with the correct serial number. If you have any questions, contact Director, Regulatory Affairs at 781-345-9001 or email: kara.johnson@conformis.com.
Quantity in Commerce 2
Distribution US Distribution in CA.
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 = LPH and Original Applicant = Conformis, Inc.
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