| Class 2 Device Recall NonSterile and Sterile Procedural Trays | |
Date Initiated by Firm | November 17, 2022 |
Date Posted | January 27, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1035-2023 |
Recall Event ID |
91387 |
Product Classification |
Orthopedic tray - Product Code OJH
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Product | Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case |
Code Information |
Item Number: DYNJ904310F, UDI/GTIN Case: 40195327116188, UDI/GTIN Each: 10195327116187, Lot Number: 22IBD724;
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Recalling Firm/ Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield 3 Lakes Dr Northfield IL 60093-2753
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For Additional Information Contact | Karin Johnson 886-359-1704 |
Manufacturer Reason for Recall | Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging. |
FDA Determined Cause 2 | Device Design |
Action | Medline Industries, LP notified consignees via email and first-class mail on 11/21/2022. Consignees were instructed to over-label the sterile kits with a warning label indicating Warning To Avoid Injury, Please Handle Blades with Care . For the Non-Sterile kits, they are to over label the affected kits indicating to remove the blades and replace from a different sterile supply. No product is to be returned. Customers were also instructed to complete and return the response form. |
Quantity in Commerce | 16 units |
Distribution | US Nationwide distribution in the states of AR, MD, WA, WI. |
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 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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