Date Initiated by Firm |
November 20, 2017 |
Create Date |
March 19, 2018 |
Recall Status1 |
Terminated 3 on June 07, 2019 |
Recall Number |
Z-1117-2018 |
Recall Event ID |
79268 |
510(K)Number |
K060192
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L
The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed. |
Code Information |
Product Code KC-2206L, Lot # 26519 |
Recalling Firm/ Manufacturer |
OMNIlife science Inc. 480 Paramount Dr Raynham MA 02767-1085
|
For Additional Information Contact |
Christina Rovaldi 508-824-2444
|
Manufacturer Reason for Recall |
The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is
marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
|
FDA Determined Cause 2 |
Incorrect or no expiration date |
Action |
OMNIlife science, Inc. sent an Urgent Medical Device Advisory Notice dated November 20, 2017.
Actions to be taken by the Customer/User
"Immediately quarantine lot 26519 for KC-2206L
"Return Product Using RMA# XXXX to OMNI.
"This advisory notice only includes LOT 26519. It does not affect other lots.
You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form and accompanying by FAX to 508-819-3390 or my email to CS@omnils.com. For further questions, please call (508) 824-2444. |
Quantity in Commerce |
32 |
Distribution |
Worldwide Distribution - US Distribution and to the country Spain. |
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 = JWH and Original Applicant = OMNI LIFE SCIENCE, INC.
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