Class II — Linkbio Corp.
| Recalling firm | LinkBio Corp. |
|---|---|
| Registered facility | LinkBio Corp. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left). |
| Product | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13 |
| Quantity | 11 units |
| Distribution | US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX |
| Initiated | 2023-04-25 |
| Classified | 2023-06-01 |
| Recall number | Z-1674-2023 |
| 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-1674-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92294/
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