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U.S. Department of Health and Human Services

Class 2 Device Recall Total Knee Pack

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  Class 2 Device Recall Total Knee Pack see related information
Date Initiated by Firm February 25, 2022
Create Date April 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0864-2022
Recall Event ID 89671
Product Classification Orthopedic tray - Product Code OJH
Product Total Knee Pack - Surgical Kit
Code Information SKU/Part Number 570-2676; UDI H65257026760 Lot Numbers: 20156461673, 20171461909, 20174462304, 20239463246, 20342468026, 21130473544, 21286478854, 21326479944, 22005482064
Recalling Firm/
Stradis Medical, LLC dba Stradis Healthcare
3025 Northwoods Pkwy
Peachtree Corners GA 30071-1524
For Additional Information Contact Kristy Wynn
Manufacturer Reason
for Recall
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
FDA Determined
Cause 2
Process change control
Action A copy of the final recall letter was sent to all affected consignees via 1st class USPS mail on February 25, 2022. The consignees were instructed that the use of further distribution of the potentially perforated kits should immediately cease. Instructions were provided to return any unused Surgical Kits with the scope of this recall to Stradis Healthcare s facility in Georgia. Periodic effectiveness checks will be conducted in order to follow-up with consignees to ensure effectiveness.
Quantity in Commerce 76 units
Distribution US Nationwide distribution in the states of IN, TX, 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.