Class II — Linkbio Corp.
| Recalling firm | LinkBio Corp. |
|---|---|
| Registered facility | LinkBio Corp. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 |
| Product | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09 |
| Quantity | 12 units |
| Distribution | NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus |
| Initiated | 2023-03-21 |
| Classified | 2023-05-04 |
| Recall number | Z-1519-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Linkbio Corp. (Z-1519-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92088/
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