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.
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.
This product is an implant component used in the Endo-Model SL system with a PE-Plateau. It is distributed globally and used by healthcare professionals in surgical settings.
A longitudinal fracture can cause the bushing to detach from the screw shaft, potentially affecting implant stability and patient safety.
This recall is not described as part of a broader industry pattern in the provided data.
No injuries reported to date. The hazard is high and could necessitate medical intervention if an affected implant is encountered.
Recall notice, device labeling, UDI information, and manufacturer communications
The recall timeline for refunds or replacements is not specified. Typical industry timelines range from 4-8 weeks, depending on the provider.
Keep the recall letter, packaging and labeling, model number, UDI, list of serial/lot numbers, photos, and all communications with providers and manufacturers
Item Number: 16-2840/07 UDI-DI: 04026575359257 Serial/Lot Numbers: 250925/0480, 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489, 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345, 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352 Quantity: 31 units Sold worldwide; US nationwide distribution in New Jersey; Countries: Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia Price: Unknown Sold From/To: 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 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/
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 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.