Z-1374-2025Class II

Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm

Name: Z-1374-2025 Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2025-02-14
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2025-02-14 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13 on 2025-02-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1374-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-14
Posted: 2025-03-17
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 [email protected] 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.
Quantity in commerce: 20 units
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.
Product codes and lots: Product Code: 880-601/13; UDI-DI: 04026575443949; Lot Numbers: 1943277, 1943280.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1374-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1372-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1373-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17
Z-1374-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-17

Product code JWH

K202924Class IILinkSymphoKnee SystemWaldemar Link GmbH & Co. KG / cleared 2021-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)