LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM… — Class II medical device recall Z-1545-2023
Ongoing recall by Linkbio Corp., reported 2023-05-10, distributed in NV, NY. Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on
| Recall number | Z-1545-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linkbio Corp., Rockaway, NJ, United States |
| Recall initiated | 2023-03-21 |
| Classified | 2023-05-04 |
| Reported by FDA | 2023-05-10 |
| Distributed | NV, NY |
| Countries outside the US | AR, AT, AU, BG, CH, CN, CO, DE, ES, FR, GB, IN, IQ, IT, JO, MX, NO, PL, SA, SE, SK, UA, VN |
| Quantity | 5 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04026575429141 |
| Model numbers | 15-2230/04 |
Product
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
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
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-1545-2023. 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.