LinkSymphoKnee recallZ-2541-2025 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jul 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2541-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2025
- Posted by the FDA
- Sep 8, 2025
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 8 units
- Product code
- JWH
- FDA submissions
- K202924
- Distribution
- Worldwide - US Nationwide distribution in the states of CO, IN, NJ, TX and the countries of Germany and Italy.
Product description
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LinkSymphoKnee 880-100/50WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
Product lines
Other devices under the same FDA submission
116 devices cleared under K202924 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LinkSymphoKnee 880-307/11WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- LinkSymphoKnee 880-325/13WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls1 report
- LinkSymphoKnee 880-305/11WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- LinkSymphoKnee 880-305/22WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- LinkSymphoKnee 880-313/11WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- LinkSymphoKnee 880-313/22WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- LinkSymphoKnee 880-315/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- LinkSymphoKnee 880-300/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- LinkSymphoKnee 880-301/11WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- LinkSymphoKnee 880-301/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- LinkSymphoKnee 880-303/11WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page