Rti Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 1,033
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Rti Surgical, Inc. makes
RTI Surgical, Inc. manufactures spinal interbody fusion cages made from polymeric materials, orthopaedic fixation systems and associated surgical kits, reusable implant templates, and human-derived bone matrix implants. Their portfolio includes orthopaedic tools such as reusable inserters, trial-implant holders, bone curettes, and power tool attachments for drilling. They also supply meniscus allografts for transplantation and lateral plate systems for spinal or joint stabilization.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Their products are regulated under U.S. medical device laws, with specific authorisation requirements depending on the device class. The manufacturer is based in the United States.
Catalogue
Search and filter all 1,033 devicesShowing 1-50 of 1,033
Company details
- DUNS number
- 117560455
- [email protected]
- Phone
- +1(906)226-9909
FDA recalls
FDA recall records list 3 recalls initiated by Rti Surgical, Inc., the earliest on 2013-10-07 and the most recent on 2017-01-23. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 23 Jan 2017 Z-1441-2017 Class II Terminated Incorrect instructions for use (IFU) included.
2013
- 6 Dec 2013 Z-0939-2014 Class II Terminated RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.
- 7 Oct 2013 Z-0627-2014 Class II Terminated As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requirement for labeling as a partial Vertebral Body Replacement Device (VBR). While the use of this device as a partial VBR is unlikely due to the size of the device, use of this device as a partial VBR could result in a s
Frequently asked questions
How many devices does Rti Surgical, Inc. have in the registry?
The registry currently lists 1033 devices for Rti Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rti Surgical, Inc.'s devices?
Among its 50 most recently registered devices, Rti Surgical, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Rti Surgical, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Rti Surgical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Rti Surgical, Inc.?
FDA recall records list 3 recalls initiated by Rti Surgical, Inc., the most recent initiated on 23 Jan 2017. 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 Rti Surgical, Inc. in the registry?
The most recently registered devices listed for Rti Surgical, Inc. include C-Plus PEEK IBF System 723-629, Cross-Fuse® II PEEK IBF System 38-INSERTER-18, Cross-Fuse® II PEEK IBF System 38-A-TRIAL-22-17 and Cross-Fuse® II PEEK IBF System 38-1870-11-12L.