Waldemar Link GmbH & Co. KG recalled 4 Endo-Model Replacement Plateau devices, Item Number 15-8030/12, sold to hospitals and clinics worldwide including New Jersey. The defect involves a plateau screw, where a longitudinal fracture could cause the bushing to detach from the screw shaft. Healthcare providers and patients should stop using the device immediately and follow recall instructions from/
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Endo-Model Replacement Plateau components are used in orthopedic implants to secure or position a plateau screw in specific device configurations. They are intended for surgical use under professional care.
A longitudinal fracture may detach the bushing from the screw shaft, potentially compromising implant integrity and function.
This recall is not described as part of a broader industry pattern in the provided information.
The recall affects a small number of units (4) and may require medical evaluation, surgical planning, and potential device replacement coordinated by healthcare providers.
Device packaging, implant records, and facility procurement notes contain identifiers; the FDA recall page provides official information.
Refunds or replacements are not specifically timed in the recall; expect hospital coordination with the manufacturer for remedies.
Keep a copy of the recall notice, device identifiers, serial numbers, and all correspondence with health care providers and manufacturers.
Item Number: 15-8030/12. UDI-DI: 04026575048151. Serial numbers: 250721/0194; 250721/0212; 250721/0211; 250721/0209. Sold to hospitals and clinics worldwide, including the US state of New Jersey. Quantity recalled: 4 units. Distribution: Worldwide; Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Price: Unknown.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Waldemar Link recalled 7 Endo-Model Replacement Plateau devices distributed worldwide, including New Jersey. The recall targets an implant component where a bushing could detach from the screw shaft after a longitudinal fracture. Healthcare providers and patients should stop using the device and follow recall instructions provided by the manufacturer.
Waldemar Link recalled 3 Endo-Model Replacement Plateau implants distributed worldwide, including New Jersey. The devices carry a risk that a bushing could detach from the plateau screw shaft due to a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow manufacturer recall instructions.
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.
Waldemar Link recalled 31 Endo-Model SL Connection Components incl. PE-Plateau sold worldwide, including New Jersey. The device bears a risk that the bushing could detach from the screw shaft due to a longitudinal fracture. Clinicians and patients should stop using the device immediately and follow manufacturer instructions.
Waldemar Link recalled 7 Endo-Model Replacement Plateau implants worldwide, including a NJ distribution. The defect could cause the bushing to detach from the screw shaft after a longitudinal fracture. Health providers should stop use and await recall instructions.