L-Shaped Femoral Augment — Class II medical device recall Z-1701-2025

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-1701-2025`
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	441 units
UPC / GTIN / UDI-DI	`04026575258048`, `04026575258055`, `04026575258062`, `04026575258079`, `04026575258086`, `04026575258109`, `04026575258123`, `04026575258147`, `04026575258154`, `04026575258161`, `04026575258178`, `04026575258185`
Model numbers	`880-320/12`

Product

L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented 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-1701-2025. 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.