LINK SymphoKnee System L-Shaped Femoral Augment — Class II medical device recall Z-1674-2023
Ongoing recall by Linkbio Corp., reported 2023-06-07, distributed nationwide. Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the i
| Recall number | Z-1674-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Linkbio Corp., Rockaway, NJ, United States |
| Recall initiated | 2023-04-25 |
| Classified | 2023-06-01 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| UPC / GTIN / UDI-DI | 04026575258123 |
| Lot numbers | 1910003 |
| Model numbers | 880-325/13 |
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
Reason for recall
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).
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-1674-2023. 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.