Aesculap Implant Systems LLC
FDA Regulatory Profile
Aesculap Implant Systems LLC appears in FDA public data with 62 recalls, 51 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2518-2023, Class II) was initiated on July 20, 2023. Its most recent 510(k) clearance was granted on July 1, 2022.
Summary
- Total Recalls
- 62
- 510(k) Clearances
- 51
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2518-2023 | Class II | For intraventricular indications mainly used for operations within the brain ventricles. Product Co | July 20, 2023 |
| Z-2146-2023 | Class II | Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable A | May 18, 2023 |
| Z-1569-2023 | Class II | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutti | March 21, 2023 |
| Z-1430-2023 | Class II | Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) B | February 23, 2023 |
| Z-1638-2022 | Class II | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental st | July 15, 2022 |
| Z-1516-2022 | Class II | Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010 | July 14, 2022 |
| Z-1410-2022 | Class II | MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441 | October 25, 2021 |
| Z-1406-2022 | Class II | LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. | June 30, 2021 |
| Z-1405-2022 | Class II | RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. | June 30, 2021 |
| Z-2579-2021 | Class II | PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 | April 16, 2021 |
| Z-2578-2021 | Class II | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU | April 16, 2021 |
| Z-2511-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL C | March 19, 2021 |
| Z-2514-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBI | March 19, 2021 |
| Z-2516-2021 | Class II | Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM | March 19, 2021 |
| Z-2515-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMU | March 19, 2021 |
| Z-2509-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL C | March 19, 2021 |
| Z-2512-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL C | March 19, 2021 |
| Z-2510-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL C | March 19, 2021 |
| Z-2513-2021 | Class II | Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL C | March 19, 2021 |
| Z-1409-2022 | Class II | Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010 | February 19, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213871 | Ennovate Cervical Spinal and Occiput System | July 1, 2022 |
| K210963 | ENNOVATE Spinal System | July 19, 2021 |
| K180433 | ENNOVATE® | April 26, 2018 |
| K162134 | ENNOVATE Spinal System | December 14, 2016 |
| K153700 | Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments | July 8, 2016 |
| K153629 | ArcadiusXP C Spinal System | May 25, 2016 |
| K153396 | Aesculap OrthoPilot Next Generation | May 16, 2016 |
| K151938 | S4 Cervical Spinal and Occiput Systems | October 21, 2015 |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | August 13, 2015 |
| K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System | May 29, 2015 |
| K141694 | AESCULAP ORTHOPILOT NEXT GENERATION | February 24, 2015 |
| K150062 | Excia Total Hip System | February 9, 2015 |
| K143106 | VEGA Knee System | November 21, 2014 |
| K140915 | EXCIA TOTAL HIP SYSTEM | July 21, 2014 |
| K140452 | VEGA KNEE SYSTEM | March 25, 2014 |
| K132421 | AESCULAP PEEK XP SPINAL IMPLANT SYSTEM | January 22, 2014 |
| K131167 | UNIVATION | October 17, 2013 |
| K123939 | S4 SPINAL SYSTEM | March 12, 2013 |
| K120955 | COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM | December 17, 2012 |
| K123352 | S4 SPINAL SYSTEM | December 12, 2012 |