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U.S. Department of Health and Human Services

Class 2 Device Recall ARTHROSCOPY Convenience kit

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 Class 2 Device Recall ARTHROSCOPY Convenience kitsee related information
Date Initiated by FirmOctober 04, 2024
Date PostedNovember 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0350-2025
Recall Event ID 95563
Product Classification Orthopedic tray - Product Code OJH
ProductARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C
Code Information UDI-DI: 10195327246747; Lot Numbers: 24GBI464 24HBO800
FEI Number 1417592
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall		Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn URGENT MEDICAL DEVICE NOTIFICATION dated 10/4/24 was sent to the customer. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.The login for completing the response form is:Website link: https://recalls.medline.comRecall Reference #: R-24-207-FGX1Recall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce80 units
DistributionUS Nationwide distribution in the state of TN.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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