FDA recall Z-1372-2025

Waldemar Link GmbH & Co. KG (Mfg Site) · Class II · device

Product

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

Reason for recall

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.

Distribution

Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.

Key facts

Status
Ongoing
Initiation date
2025-02-14
Report date
2025-03-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2025