LOSPA Tibial Insert Model/Catalog Number: See below Software Version:… — Class II medical device recall Z-1934-2024
Ongoing recall by CORENTEC CO., LTD, reported 2024-06-12, distributed nationwide. Due to unsupported 10 year expiration date.
| Recall number | Z-1934-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CORENTEC CO., LTD, Cheonan, N/A, Korea (the Republic of) |
| Recall initiated | 2024-03-29 |
| Classified | 2024-05-31 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 397 |
| Model numbers | 01.10.1XX, 01.10.2XX, 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 |
Product
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Reason for recall
Due to unsupported 10 year expiration date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1934-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.