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Aesculap Implant Systems LLC FDA Recalls
20 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399RClass IIJul 20, 2023Trocar manufactured with the shaft too long and does not mee |
| Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610Class IIMay 18, 2023Incorrect product code marked on the product, etched with pr |
| Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablatClass IIMar 21, 2023Potential for the spring to become loose and fall out of the |
| Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Class IIFeb 23, 2023Mislabeled: Product is marked with GTIN # 04046955299592 how |
| Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lClass IIJul 15, 2022Potential for the incorrect screw to be included in the pack |
| Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010Class IIJul 14, 2022Application error problems: Rebalance scope message: 1.Rebal |
| MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441Class IIOct 25, 2021Set screwdriver fails during surgery by deforming at the tip |
| LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.Class IIJun 30, 2021Customized coronal rod benders may deform the implant when u |
| RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.Class IIJun 30, 2021Customized coronal rod benders may deform the implant when u |
| PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUClass IIApr 16, 2021Malfuncton-Implant did not deploy successfully may necessit |
| PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13Class IIApr 16, 2021Malfuncton-Implant did not deploy successfully may necessit |
| Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NClass IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NClass IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NClass IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NClass IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation SetClass IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; Class IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NClass IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; Class IIMar 19, 2021Malfunction- loosening of the implant resulting in a potenti |
| Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010Class IIFeb 19, 2021Malfunction of the robotic arm preventing further movement o |