Date Initiated by Firm |
July 20, 2020 |
Create Date |
August 22, 2020 |
Recall Status1 |
Terminated 3 on June 21, 2021 |
Recall Number |
Z-2849-2020 |
Recall Event ID |
86174 |
510(K)Number |
K180906
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) |
Code Information |
Serial Number: 0469247 Exp. 2021-01-31 |
Recalling Firm/ Manufacturer |
Conformis, Inc. 600 Technology Park Dr Billerica MA 01821-4154
|
For Additional Information Contact |
SAME 781-345-9001
|
Manufacturer Reason for Recall |
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Conformis notification to field sales representative on July 20,2020 to remove product from use. |
Quantity in Commerce |
1 kit |
Distribution |
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 = JWH and Original Applicant = Conformis, Inc.
|