LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
FDA device recall Z-1934-2024 · posted 2024-05-31 · Open, Classified
Recall details
- Recalling firm
- CORENTEC CO., LTD
- Reason for recall
- Due to unsupported 10 year expiration date.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 397
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
- Date initiated
- 2024-03-29
- Date posted
- 2024-05-31
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| EAUM TOTAL KNEE SYSTEM (K110404) | Corentec Co., Ltd. | 2012-02-16 |