• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall iTotal Hip

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall iTotal Hipsee related information
Date Initiated by FirmAugust 22, 2019
Create DateOctober 08, 2019
Recall Status1 Terminated 3 on July 08, 2020
Recall NumberZ-0063-2020
Recall Event ID 83760
510(K)NumberK162719 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductiTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Code Information 0448088
Recalling Firm/
Manufacturer
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information ContactPaul 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
ActionConformis 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 Commerce1
DistributionDistributed to consignees in MD and NV.
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
-
-