Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Couplin... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – the device has been delivered with a ... (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
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Brand
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
Lot Codes / Batch Numbers
Item Number: 15-0028/08, UDI-DI: 04026575175222, Lot Number: 2535004
Products Sold
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany is recalling Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Tape due to The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral componen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Recommended Action
Per FDA guidance
On November 10, 2025, URGENT: MEDICAL DEVICE RECALL letters were emailed to distributors. Actions to be taken: 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. 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.
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 noticeDistribution
As reported by FDA
AL, GA, TX
Page updated: Jan 10, 2026