Recall Z-1549-2023— Linkbio Corp.
Class II · Ongoing
Class II FDA medical device recall by Linkbio Corp., initiated 2023-03-21. It names 2 FDA 510(k) clearances: K212742, K152431. Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10. Reason: Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected.
- Recalling firm
- Linkbio Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-21
- Firm location
- Rockaway, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K212742 — GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
- K152431 — LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
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
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
Reason for recall
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Data sourced from openFDA. This site is unofficial and independent of the FDA.