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.
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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The Endo-Model Replacement Plateau is an orthopedic implant component used in surgical procedures to stabilize certain bone segments. Implants like this are critical to patient rehabilitation and require precise integration with surrounding hardware.
A longitudinal fracture could cause the plateau screw bushing to detach from the screw shaft, creating a mechanical failure risk that may necessitate revision surgery.
This recall is not described as part of a broader industry pattern in the notice.
The recall affects 7 implanted devices distributed worldwide. Patients may require evaluation and possible surgery to address component detachment.
Identifiers appear on device labeling, packaging, or accompanying documentation.
Manufacturer guidance will outline removal or replacement timelines; recalls of implants typically involve coordinated medical scheduling.
Document recall communications, device identifiers, and notes from healthcare providers; retain all packaging and documentation for records.
Item Number: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Numbers: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227; Quantity: 7 units (OUS only); Sold worldwide including US NJ; Recall date: 2026-01-12; Status: ACTIVE; Manufacturer: Waldemar Link GmbH & Co. KG; Recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1519-2026; Category: Medical Devices.
No injuries or incidents have been reported.
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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.
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