Waldemar Link GmbH & Co. KG recalled 49 SL Connection Components sold worldwide after reports of potential detachment of the bushing from the screw shaft. A longitudinal fracture could occur, posing serious risks to patients. Patients and healthcare providers should stop using the device immediately and follow 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 SL Connection Component is a medical device used in surgical procedures involving implants. It provides essential support and fixation for various types of implants.
The defect in the SL Connection Component can cause the bushing to detach from the screw shaft due to a longitudinal fracture. This may lead to serious complications during implantation.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face immediate risk if the product is used, making it critical to cease all use and follow recall protocols.
Serial numbers and item numbers can usually be found on the packaging or the device itself.
Expect a timeline of 4-6 weeks for processing any refunds or replacements.
Keep all communication regarding the recall, including emails, letters, and any correspondence with the manufacturer.
- Item Number: 16-2840/02 - Serial/Lot Numbers: 250925/0640, 250925/0641, 250925/0642, 250925/0646, 250925/0650, 250925/0652, 250925/0653, 250925/0656, 250925/0658, 250925/0669, 250925/0670, 250925/0680, 250925/0681, 250925/0682, 250925/0687, 250925/0689, 250925/0690, 250925/0691 - Distributed: Worldwide, including US (New Jersey), Belarus, Canada, Switzerland, Colombia, Germany, Spain, UK, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
No injuries or incidents have been reported.
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