LinkSymphoKnee Distal Femoral Augment — Class II medical device recall Z-2066-2023
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2023-07-12, distributed nationwide. Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal
| Recall number | Z-2066-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, N/A, Germany |
| Recall initiated | 2022-12-23 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 04026575257379 |
| Lot numbers | 2123225 |
Product
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Reason for recall
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
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-2066-2023. 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.