FDA Device recall Z-1374-2025
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13 by Waldemar Link And Kg Mfg Site, citing A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1374-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-14 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Mfg Site |
| Distribution | US |
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Reason
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Identifiers
| code_info | Product Code: 880-601/13; UDI-DI: 04026575443949; Lot Numbers: 1943277, 1943280. |
|---|
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-1374-2025%22
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