FDA Medical devices recall ·
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm… recall
- Recall number
- Z-1373-2025
- Date
- (initiated February 14, 2025)
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10, Norderstedt, N/A, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 52 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Product Code: 880-601/12; UDI-DI: 04026575443932; Lot Numbers: 1943274, 1943276, 2049172, 2049173, 2049175.
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.
States: Alabama California Colorado Florida Georgia Indiana Kansas Missouri New Jersey Nevada Ohio Texas Virginia Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1373-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.