Nextremity Solutions, Inc.
Active in EUDAMEDAlso registered as Nextremity Solutions, Nextremity Solutions, LLC
United Statesfrom EUDAMED address EUDAMED SRN US-MF-000008441
- Devices
- 20
- Registrations
- EUDAMED
- FDA recalls
- 15
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA recalls
Catalogue
Search and filter all 20 devicesCompany details
- EUDAMED SRN
- US-MF-000008441
- EUDAMED status
- Active
- EUDAMED registered name
- Nextremity Solutions, Inc.
- EUDAMED abbreviated name
- Nextremity Solutions
- [email protected]
- PRRC contact
- Travis Christman
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 5
- 2020 1
- 2021 2
- 2022 7
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 10 Feb 2022 Z-0910-2022 Class II Terminated Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- 10 Feb 2022 Z-0911-2022 Class II Terminated Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- 10 Feb 2022 Z-0912-2022 Class II Terminated Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- 10 Feb 2022 Z-0913-2022 Class II Terminated Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- 10 Feb 2022 Z-0914-2022 Class II Terminated Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
- 13 Jan 2022 Z-0739-2022 Class II Terminated During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
- 13 Jan 2022 Z-0740-2022 Class II Terminated During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision
2021
- 26 Mar 2021 Z-1500-2021 Class II Terminated Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
- 26 Mar 2021 Z-1501-2021 Class II Terminated Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
2020
- 12 Feb 2020 Z-1458-2020 Class II Terminated Proximal end of the driver in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
Show all 15 recalls
2019
- 16 Dec 2019 Z-1127-2020 Class II Terminated The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
- 11 Nov 2019 Z-0776-2020 Class II Terminated Components 2mm shorter than indicated on the package label
- 11 Nov 2019 Z-0777-2020 Class II Terminated Components 2mm shorter than indicated on the package label
- 11 Nov 2019 Z-0778-2020 Class II Terminated Components 2mm shorter than indicated on the package label
- 9 Oct 2019 Z-0534-2020 Class II Terminated Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
Frequently asked questions
How many devices does Nextremity Solutions, Inc. have in the registry?
The registry currently lists 20 devices for Nextremity Solutions, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nextremity Solutions, Inc.'s devices?
Among its 20 most recently registered devices, Nextremity Solutions, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Nextremity Solutions, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Nextremity Solutions, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nextremity Solutions, Inc.?
FDA recall records list 15 recalls initiated by Nextremity Solutions, Inc., the most recent initiated on 10 Feb 2022. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Nextremity Solutions, Inc. in the registry?
The most recently registered devices listed for Nextremity Solutions, Inc. include Stratum® Ankle Fusion Plating System, InCore Subtalar System, Stratum™ Reduced Size Foot Plating System and AXI+LINE Proximal Bunion Correction System.