Implant Resource, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1000139815
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 11 ongoing
What Implant Resource, Inc. makes
Implant Resource, Inc. manufactures orthopedic fixation hardware, including pins and wires for internal bone stabilization, as well as replacement batteries for the Stryker 2115 surgical device.
Their products are regulated under FDA Class I and Class II classifications, with relevant devices listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Pins And Wires Ref K002125
Regimes: 510(k) Registry: 510(k)Stryker 2115 Replacement Battery (2115) Ref K970378
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1000139815
- Address
- 917 Lone Oak Rd, Suite 1000, Eagan, MN, 55121
FDA recalls
FDA recall records list 1 recall initiated by IMPLANT RESOURCE, INC., initiated on 2021-07-21. By recorded status: 1 ongoing. The reasons filed fall into these groups: mechanical integrity. 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 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 21 Jul 2021 Z-0122-2022 Class II Ongoing Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
Frequently asked questions
How many devices does IMPLANT RESOURCE, INC. have in the registry?
The registry currently lists 2 devices for IMPLANT RESOURCE, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list IMPLANT RESOURCE, INC.'s devices?
Among its 2 most recently registered devices, IMPLANT RESOURCE, INC. has devices listed in FDA 510(k) (2 devices).
What risk classes do IMPLANT RESOURCE, INC.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for IMPLANT RESOURCE, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for IMPLANT RESOURCE, INC.?
FDA recall records list 1 recall initiated by IMPLANT RESOURCE, INC., the most recent initiated on 21 Jul 2021. 1 of them is recorded as ongoing. 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 IMPLANT RESOURCE, INC. in the registry?
The most recently registered devices listed for IMPLANT RESOURCE, INC. include PINS AND WIRES and STRYKER 2115 REPLACEMENT BATTERY (2115).