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U.S. Department of Health and Human Services

Class 2 Device Recall iTotal Hip

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  Class 2 Device Recall iTotal Hip see related information
Date Initiated by Firm August 22, 2019
Create Date October 08, 2019
Recall Status1 Terminated 3 on July 08, 2020
Recall Number Z-0064-2020
Recall Event ID 83760
510(K)Number K162719  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Code Information 0447621
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact Paul Smolenski
781-374-5586
Manufacturer Reason
for Recall		 Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
FDA Determined
Cause 2		 Under Investigation by firm
Action Conformis was notified of the issue on 8/22/19 when a customer reported that there had been a package mix-up. Conformis immediately contacted the customer associated with the other serial number involved in the mix-up and requested the return of that stem. Conformis is not aware of any other instances of mixed product.
Quantity in Commerce 1
Distribution Distributed to consignees in MD and NV.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ConforMIS, Inc.
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