Tibial Augment — Class II medical device recall Z-1702-2025
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-1702-2025 |
|---|---|
| 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 | 1,771 units |
| UPC / GTIN / UDI-DI | 04026575258192, 04026575258208, 04026575258215, 04026575258222, 04026575258246, 04026575258253, 04026575258260, 04026575258277, 04026575258284, 04026575258291, 04026575258307, 04026575258314, 04026575258321, 04026575258338, 04026575258345, 04026575258352, 04026575258369, 04026575258376, 04026575258383, 04026575258390, 04026575258406, 04026575258413, 04026575258420, 04026575258437, 04026575258475 and 5 more |
| Model numbers | 1-2, 880-331/11 |
Product
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7) 880-333/11 (Sz. 3-4 - cemented x-sm), (8) 880-333/12 (Sz. 3-4 - cemented sm), (9) 880-333/13 (Sz. 3-4 - cemented md), (10) 880-333/21 (Sz. 3-4 - cemented lg), (11) 880-333/22 (Sz. 3-4 - cemented x-lg), (12) 880-333/23 (Sz. 3-4 - cemented xx-lg), (13) 880-335/11 (Sz. 5-6 - cemented x-sm), (14) 880-335/12 (Sz. 5-6 - cemented sm), (15) 880-335/13 (Sz. 5-6 - cemented md), (16) 880-335/21 (Sz. 5-6 - cemented lg), (17) 880-335/22 (Sz. 5-6 - cemented lg), (18) 880-335/23 (Sz. 5-6 - cemented xx-lg), (19) 880-337/11 (Sz. 7-8 - cemented x-sm), (20) 880-337/12 (Sz. 5-6 - cemented sm), (21) 880-337/13 (Sz. 7-8 - cemented md), (22) 880-337/21 (Sz. 7-8 - cemented lg), (23) 880-337/22 (Sz. 7-8 - cemented x-lg), (24) 880-337/23 (Sz. 7-8 - cemented xx-lg), (25) 880-339/11 (Sz. 9-10 - cemented x-sm), (26) 880-339/12 (Sz. 9-10 - cemented sm), (27) 880-339/13 (Sz. 9-10 - cemented md), (28) 880-339/21 (Sz. 9-10 - cemented lg), (29) 880-339/22 (Sz. 9-10 - cemented x-lg), (30) 880-339/23 (Sz. 9-10 - cemented xx-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-1702-2025. 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.