LOSPA Patella Component recallZ-1935-2024 · Corentec CO., Ltd · initiated Mar 29, 2024
Class II Open, Classified All recalls posted in May 2024
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Corentec CO., Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to unsupported 10 year expiration date.
FDA root cause category: Labeling Change Control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1935-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 29, 2024
- Posted by the FDA
- May 31, 2024
- Recalling firm
- Corentec CO., Ltd
- Quantity
- 35
- Product code
- JWH
- FDA submissions
- K110404, K130673, K160157
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
Product description
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
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
Other devices under the same FDA submission
2 devices cleared under K110404, K130673, K160157 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LOSPA Total Knee System 01.10.007Corentec Co., Ltd · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- LOSPA Total Knee System 01.10.064Corentec Co., Ltd · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 94380).
- Z-1934-2024 · Open, ClassifiedLOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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