Recall Z-1934-2024— CORENTEC CO., LTD
Class II · Ongoing
Class II FDA medical device recall by CORENTEC CO., LTD, initiated 2024-03-29. It names 3 FDA 510(k) clearances: K160157, K130673, K110404. 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..
- Recalling firm
- CORENTEC CO., LTD
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-29
- Firm location
- Cheonan, N/A, Korea (the Republic of)
510(k) clearances named in this recall
3 on FDA's record- K160157 — LOSPA Modular Knee System
- K130673 — LOSPA TOTAL KNEE REPLACEMENT SYSTEM
- K110404 — EAUM TOTAL KNEE SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.