FDA Device recall Z-1935-2024
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella by Corentec, citing due to unsupported 10 year expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1935-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-29 |
| Published | 2024-06-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Corentec |
| Distribution | US |
Product
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
Reason
Due to unsupported 10 year expiration date.
Identifiers
| code_info | Lot Code: Model No: 01.10.9XX UDI/Lot Numbers: See attached Lospa recall Attachment 1 Lospa Knee System 01.10.921 LOSPA…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1935-2024%22
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