Class 2 Device Recall GEOMED

• Date Initiated by Firm: November 03, 2022
• Date Posted: December 15, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0568-2023
• Recall Event ID: 91134
• Product Classification: General surgery tray - Product Code LRO
• Product: GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
• Code Information: Lot Numbers: Lot 56392226 exp 9/1/2023; Lot 56683525 exp 9/1/2023; Lot 57001506 exp 4/1/2024
• Recalling Firm/ Manufacturer: DeRoyal Industries Inc; 200 Debusk Ln; Powell TN 37849-4703
• For Additional Information Contact: Theresa Marsee; 865-938-7828
• Manufacturer Reason for Recall: DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm issued an URGENT RECALL NOTICE to its consignees on 11/03/2022 by email and US mail. 1) Using the attached Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and place in quarantine to prevent further use. 2) DeRoyal will contact you to schedule time to affix labels to all affected product. These labels indicate that, at the time of use, the affected product should be removed from the kit/tray and destroyed. These products should be destroyed according to your facility, local, state and federal regulations. 3) DeRoyal representative will determine kits/trays and affected lot numbers which require the labeling indicating to remove 3M Health Care item. 4) The completed the NOTICE OF DESTRUCTION FORM shall be emailed to recalls@deroyal.com no later than 12/8/2022. PLEASE COMPLETE THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 5) The remaining items in the kit/tray are unaffected and may still be used. Distributors were asked to perform the following: "1) Using the attached Distributor Affected Products Listing Spreadsheet, identify affected part/lot numbers in your inventory and request placement in quarantine to prevent further use. 2) Please notify us with the quantity of affected cases, product and lot numbers in your inventory to which labels will need to be applied. Email this to recalls@deroyal.com no later than 11/21/2022. We will immediately send labeling for you to apply to case and each pack contained within. 3) These labels indicate that, at the time of use, the affected product should be removed from the kit / tray and destroyed. 4) The remaining items in the kit/tray are unaffected and may still be used. 5) If you have questions or need assistance with the recall, please contact your DeRoyal Supplier Relations contact, customer service at 888.938.7828, or email us at recalls@deroyal.com.
• Quantity in Commerce: 135 kits
• Distribution: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi
• 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.