Distal Femoral Augment — Class II medical device recall Z-1699-2025
Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2025-05-07, distributed nationwide. The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
| Recall number | Z-1699-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany |
| Recall initiated | 2025-04-03 |
| Classified | 2025-04-30 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,180 units |
| UPC / GTIN / UDI-DI | 04026575257102, 04026575257133, 04026575257140, 04026575257171, 04026575257188, 04026575257195, 04026575257201, 04026575257256, 04026575257263, 04026575257270, 04026575257287, 04026575257379, 04026575257386, 04026575257393, 04026575257409, 04026575257454, 04026575257461, 04026575257478, 04026575257485, 04026575284931 |
| Model numbers | 880-300/11 |
Product
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 880-303/21 (Sz. 3-4 - cemented lg), (8) 880-303/22 (Sz. 3-4 - cemented x-lg), (9) 880-305/11 (Sz. 5-6 - cemented sm), (10) 880-305/12 (Sz. 5-6 - cemented md), (11) 880-305/21 (Sz. 5-6 - cemented lg), (12) 880-305/22 (Sz. 5-6 - cemented x-lg), (13) 880-307/11 (Sz. 7-8 - cemented sm), (14) 880-307/12 (Sz. 7-8 - cemented md), (15) 880-307/21 (Sz. 7-8 - cemented lg), (16) 880-307/22 (Sz. 7-8 - cemented x-lg), (17) 880-309/11 (Sz. 9-10 - cemented sm), (18) 880-309/12 (Sz. 9-10 - cemented md), (19) 880-309/21 (Sz. 9-10 - cemented lg), (20) 880-309/22 (Sz. 9-10 - cemented x-lg).
Reason for recall
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
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-1699-2025. 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.