Waldemar Link recalled 44 Endo-Model SL implant components sold through multiple distributors worldwide, including 1 unit in the United States. The bushing could detach from the screw shaft because of a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow recall instructions from Waldemar Link for returns or replacements.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: Letter
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This is a surgically implanted component used in the Endo-Model SL system with a plateau screw design. It is intended to secure a connection within an implant construct.
A longitudinal fracture can detach the bushing from the screw shaft, potentially compromising implant stability and function.
This recall is not described as part of a broader industry pattern.
Clinicians may need to stop surgeries using these components and arrange for replacement parts or re-implantation. Patients may require additional procedures to ensure implant integrity.
UDI-DI on packaging/label; Item Number on product label; recall notice from Waldemar Link
Recall notices will guide replacement or repair; timelines vary by facility
Keep recall notice, record Item Number, UDI-DI, and all serial numbers; save communications with manufacturer; photograph device labels
Item Number: 16-2840/05 UDI-DI: 04026575359240 Serial/Lot Numbers: 250513/2083, 250513/2085, 250513/2086, 250513/2089, 250513/2090, 250513/2092, 250513/2093, 250513/2097, 250513/2100, 250513/2102, 250513/2104, 250513/2107, 250513/2108, 251013/3245, 251013/3247, 251013/3250, 251013/3251, 251013/3252 Quantity: 44 units Recall Date: 2026-01-12 Status: Active Countries Distributed: Worldwide; US (NJ), Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia Sold at: Multiple Distributors
No injuries or incidents have been reported.
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