Class 2 Device Recall LOSPA Knee System

• Date Initiated by Firm: March 29, 2024
• Date Posted: May 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1935-2024
• Recall Event ID: 94380
• 510(K)Number: K110404 K130673 K160157
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
• Code Information: Lot Code: Model No: 01.10.9XX UDI/Lot Numbers: See attached Lospa recall Attachment 1 Lospa Knee System 01.10.921 LOSPA Patella Component 26mm 0108806373833922172706281000AGEM20 00AGEM20 6/28/2027 Lospa Knee System 01.10.961 LOSPA Patella Component 30mm 0108806373833984172711281010AGHP27 10AGHP27 11/28/2027 Lospa Knee System 01.10.961 LOSPA Patella Component 30mm 0108806373833984172904281010AJDR25 10AJDR25 4/28/2029 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172812281010AHL625 10AHL625 12/28/2028 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172907281010AJFR25 10AJFR25 7/28/2029 Lospa Knee System 01.10.981 LOSPA Patella Component 32mm 0108806373834011172909281010AJJ528 10ajj528 9/28/2029 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172505281010AEFC25 10AEFC25 5/28/2025 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172805281010AHCY28 10AHCY28 5/28/2028 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172904281010AJDR28 10AJDR28 4/28/2029 Lospa Knee System 01.10.9A2 LOSPA Patella Component 34mm 0108806373834059172907281010AJH625 10AJH625 7/28/2029 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172503281000AED827 00AED827 3/28/2025 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172603281000AFAM25 00AFAM25 3/28/2026 Lospa Knee System 01.10.9EC LOSPA Patella Component 38mm 0108806373853692172907281000AJDC25 00AJDC25 7/28/2029 Lospa Knee System 01.10.9GC LOSPA Patella Component 40mm 0108806373853708172901281000AJBC25 00AJBC25 1/28/2029
• Recalling Firm/ Manufacturer: CORENTEC CO., LTD; 12 Yeongsanhong1-Gil; Seobuk; Cheonan Korea (the Republic of)
• For Additional Information Contact: Michael Son; 949-290-9885
• Manufacturer Reason for Recall: Due to unsupported 10 year expiration date.
• FDA Determined Cause: Labeling Change Control
• Action: On 03/29/2024, the firm emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that on 7/1/2020 the firm changed the labeling of their polyethylene (PE) and patella inserts from a 5 year shelf life to a 10 year shelf life. This change was made without adequate documentation evidence to support the increase in shelf life. Customers are instructed to: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Maintain awareness of this notice internally until all required actions have been completed within your facility. 5. Inform Corentec if any of the subject devices have been distributed to other organizations. a. Please provide Corentec contact details so that Corentec can inform the recipients appropriately. 6. Please complete the attached customer response form (acknowledgement form). It is possible that you no longer have any physical inventory of the impacted product on site. Completing this form will allow us to update our records and will also negate the need for us to send any further communications on this matter. Therefore, please complete the customer response form even if you no longer have any of the subject devices in your physical inventory. 7. Return the completed form to Corentec. For any questions or assistance contact Bobby Pham at 310-488-2886 or via email Bobby.Pham@corentec-US.com.
• Quantity in Commerce: 35
• Distribution: US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
• 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.

• 510(K) Database: 510(K)s with Product Code = JWH