Waldemar Link GmbH & Co. KG (Mfg Site) recalls Modular Stem cylindrical

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.

Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12

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.

• FDA enforcement recordOfficial FDA database entry for Z-1373-2025
• FDA 510(k) clearance · K202924The device's official FDA premarket clearance record
• FDA device classification · JWHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Waldemar Link GmbH & Co. KG (Mfg Site)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.