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
|
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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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