FDA Device recall Z-1934-2024
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
- FDA Device
- Class II
- ongoing
- Published 2024-06-12
On 2024-06-12 the FDA classified a Class II recall of LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert by Corentec, citing due to unsupported 10 year expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1934-2024 |
| 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 Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Reason
Due to unsupported 10 year expiration date.
Identifiers
| code_info | Lot Code: LOSPA Tibial Insert (CR) Model No: 01.10.1XX LOSPA Tibial Insert (PS) Model No: 01.10.2XX LOSPA Fixed Const…Lot Code: LOSPA Tibial Insert (CR) Model No: 01.10.1XX LOSPA Tibial Insert (PS) Model No: 01.10.2XX LOSPA Fixed Constrained Tibial Insert Model No: K2.IBN.4061-XXX, K2.IBN.4264-XXX, K2.IBN.4467-XXX, K2.IBN.4672-XXX, K2.IBN.4874-XXX, K2.IBN.5076-XXX, K2.IBN.5281-XXX, K2.IBN.5684-XXX UDI/Lot Numbers: See attached Lospa recall Attachment 1 Lospa Knee System 01.10.132 Lospa Tibial Insert (CR) - Size 3 / 10mm 0108806373820953172605281070AFDM33 70AFDM33 5/28/2026 Lospa Knee System 01.10.132 Lospa Tibial Insert (CR) - Size 3 / 10mm 0108806373820953172703281070AFL130 70AFL130 3/28/2027 Lospa Knee System 01.10.134 Lospa Tibial Insert (CR) - Size 3 / 12mm 0108806373820960172605281070AFDM34 70AFDM34 5/28/2026 Lospa Knee System 01.10.134 Lospa Tibial Insert (CR) - Size 3 / 12mm 0108806373820960172712281070AFL131 70AFL131 12/28/2027 Lospa Knee System 01.10.136 Lospa Tibial Insert (CR) - Size 3 / 14mm 0108806373820977172510281070AEK548 70AEK548 10/28/2025 Lospa Knee System 01.10.136 Lospa Tibial |
|---|
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-1934-2024%22
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