Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Why it was recalled
Due to unsupported 10 year expiration date.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / 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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.
Recall record
- Recalling firm
- CORENTEC CO., LTD
- Product type
- Devices
- Recall number
- Z-1935-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Origin
- Cheonan, N/A
- Recall initiated
- 2024-03-29
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1935-2024 · Source: openFDA enforcement.