Aesculap Implant Systems LLC
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Aesculap Implant Systems LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-09-13FDA-DeviceClass IIFor intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
- 2023-07-26FDA-DeviceClass IIAesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610
Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.
- 2023-05-17FDA-DeviceClass IIAesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery. Product Code: PL771SU
Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.
- 2023-05-03FDA-DeviceClass IICaspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System
Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
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