RecallRadar

FDA Device recall Z-1372-2025

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

On 2025-03-26 the FDA classified a Class II recall of Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11 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

AgencyFDA Device
Recall numberZ-1372-2025
ClassificationClass II
Statusongoing
Initiated2025-02-14
Published2025-03-26
Last updated2026-09-13 11:57 UTC
CompanyWaldemar Link And Kg Mfg Site
DistributionUS

Product

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11

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_infoProduct Code: 880-601/11; UDI-DI: 04026575443925; Lot Numbers: 1943294, 1943296, 1943297, 2049174.

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-1372-2025%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.