Modular Stem (Waldemar Link) – Carton Label Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Brand
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
Lot Codes / Batch Numbers
Product Code: 880-601/11, UDI-DI: 04026575443925, Lot Numbers: 1943294, 1943296, 1943297, 2049174.
Products Sold
Product Code: 880-601/11; UDI-DI: 04026575443925; Lot Numbers: 1943294, 1943296, 1943297, 2049174.
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany is recalling Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880- due to 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 differ. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On February 21, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the Customer/User: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026