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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 Systemsee related information
Date Initiated by FirmSeptember 21, 2020
Create DateNovember 20, 2020
Recall Status1 Terminated 3 on June 12, 2023
Recall NumberZ-0475-2021
Recall Event ID 86615
510(K)NumberK192198 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductiTotal 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 ContactKara Johnson
781-832-5402
Manufacturer Reason
for Recall		Incorrect hip components were provided in kits.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce2
DistributionUS Distribution in CA.
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LPH
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