Osteomed Corp.
United Statesfrom the FDA registration address FDA FEI 2027754
Osteomed Corp. is a medical device manufacturer, with 8,049 devices listed and 15 FDA recalls as of 14 Nov 2026.
- Devices
- 8,049
- Registrations
- FDA
- FDA recalls
- 153 ongoing
Registry facts
- Registries
- FDA GUDID 2,999
- EUDAMED 740
- FDA 510(k) 1
- Device classes
- FDA Class II 2,919
- FDA Class I 53
- FDA Unclassified 28
- FDA recalls
- Identifiers
- FDA FEI 2027754
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Osteomed Corp. makes
Osteomed Corp. manufactures non-bioabsorbable orthopaedic hardware, including sterile and non-sterile bone screws for general internal fixation, craniofacial fixation plates and screws, and reusable instrument trays for surgical procedures. Their products are designed for skeletal stabilization in orthopaedic and craniofacial applications, such as fracture fixation and bone alignment. The company also supplies orthopaedic fixation system implantation kits for surgical use.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the United States, adhering to domestic regulatory requirements for medical device authorization.
Catalogue
Search and filter all 8,049 devicesShowing 1-50 of 8,049
Company details
- FDA FEI number
- 2027754
- Address
- 3885 Arapaho Rd, ADDISON, TX, 75001
FDA recalls
FDA recall records list 15 recalls initiated by Osteomed Corp., the earliest on 2020-04-02 and the most recent on 2023-05-31. By recorded status: 3 ongoing and 12 terminated. The reasons filed fall into these groups: labeling or instructions for use and electrical or power. 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 12
- 2021 1
- 2022 0
- 2023 2
- 2024 0
- 2025 0
- 2026 0
2023
- 31 May 2023 Z-2107-2023 Class II Ongoing Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Full distribution text
- 31 May 2023 Z-2108-2023 Class II Ongoing Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Full distribution text
- 31 May 2023 Z-2107-2023 Class II Ongoing Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
2021
- 28 Oct 2021 Z-0335-2022 Class II Ongoing Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Full distribution text
- 28 Oct 2021 Z-0335-2022 Class II Ongoing Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
2020
- 2 Apr 2020 Z-2180-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2181-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2182-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2183-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2184-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2185-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2186-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2180-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Show all 15 recalls
2020
- 2 Apr 2020 Z-2187-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2188-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2189-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2190-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2191-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Full distribution text
- 2 Apr 2020 Z-2187-2020 Class II Terminated Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Frequently asked questions
How many devices does Osteomed Corp. have in the registry?
The registry currently lists 8049 devices for Osteomed Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteomed Corp.'s devices?
Among its 50 most recently registered devices, Osteomed Corp. has devices listed in EUDAMED (12 devices), FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Osteomed Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Osteomed Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Osteomed Corp.?
FDA recall records list 15 recalls initiated by Osteomed Corp., the most recent initiated on 31 May 2023. 3 of them are 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 Osteomed Corp. in the registry?
The most recently registered devices listed for Osteomed Corp. include OSTEOMED 320-2916-14, OSTEOMED 220-0616-08, OSTEOMED 320-2227 and OSTEOMED 320-2801.