Z-2541-2025Class II

LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF...

Name: Z-2541-2025 LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2025-07-31
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2025-07-31 / Open, Classified / root cause: manufacturing process

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50 on 2025-07-31. FDA classified it as Class II and gives the reason as "Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2541-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-31
Posted: 2025-09-08
Recalling firm: Waldemar Link GmbH & Co. KG
Product: LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Waldemar Link notified consignees on about 07/31/2025 via URGENT: MEDCICAL DEVICE RECALL letter. Consignees were instructed to identify any affected units and arranging for their return to LinkBio Corporation, and to also complete and return the response form.
Quantity in commerce: 8 units
Distribution: Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Product codes and lots: REF Number: 880-100/50. UDI-DI: 04026575251278. Serial Numbers: 210125/2259, 210125/2262, 210125/2268, 210125/2260, 210125/2264, 210125/2270, 210125/2272, 210125/2273.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2541-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2541-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-08

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)