FDA Device recall Z-1699-2025
Distal Femoral Augment
- FDA Device
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Distal Femoral Augment by Waldemar Link And Kg Mfg Site, citing the device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1699-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-03 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
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
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.
Identifiers
| code_info | Item Number/UDI-DI: (1) 880-300/11 (04026575284931), (2) 880-300/21 (04026575257102), (3) 880-301/11 (04026575257133),…Item Number/UDI-DI: (1) 880-300/11 (04026575284931), (2) 880-300/21 (04026575257102), (3) 880-301/11 (04026575257133), (4) 880-301/21 (04026575257140), (5) 880-303/11 (04026575257171), (6) 880-303/12 (04026575257188), (7) 880-303/21 (04026575257195), (8) 880-303/22 (04026575257201), (9) 880-305/11 (04026575257256), (10) 880-305/12 (04026575257263), (11) 880-305/21 (04026575257270), (12) 880-305/22 (04026575257287), (13) 880-307/11 (04026575257379), (14) 880-307/12 (04026575257386), (15) 880-307/21 (04026575257393), (16) 880-307/22 (04026575257409), (17) 880-309/11 (04026575257454), (18) 880-309/12 (04026575257461), (19) 880-309/21 (04026575257478), (20) 880-309/22 (04026575257485). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1699-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.