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

Class 2 Device Recall Medline Total Knee

  • 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 Medline Total Knee see related information
Date Initiated by Firm July 01, 2021
Create Date August 09, 2021
Recall Status1 Open3, Classified
Recall Number Z-2233-2021
Recall Event ID 88268
Product Classification Orthopedic tray - Product Code OJH
Product Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
Code Information Lot 20LBF040, Exp. 2021-12-31, GTIN (01)10193489443615.
Recalling Firm/
Manufacturer
Medline Industries Inc
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Ms. Kassandra Cotner
866-359-1704
Manufacturer Reason
for Recall
The kits may contain an expired component.
FDA Determined
Cause 2
Employee error
Action Consignees were notified by letter dated and issued on 7/1/2021 via first class mail. The letter informed the consignee the convenience kits were being recalled due to the irrigation bag expiring August 21,2020. The consignee was to immediately check their stock for the affected kit and kit lot number and affix the enclosed sticker on the kit which instructs the consignee to remove the expired irrigation bag and replace it with sterile product from their supply. The remainder of the components may be used.
Quantity in Commerce 286 total kits for all products
Distribution US Nationwide distribution in the states of MN, NE, and PA.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-