Biopro, Inc.
United Statesfrom the FDA registration address FDA FEI 1832656
- Devices
- 3,018
- Registrations
- FDA
- FDA recalls
- 396 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Biopro, Inc. makes
Biopro, Inc. manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws (e.g., cortical and low-head varieties), fixation plates, non-adjustable bone staples, tibial inserts, and orthopaedic reamers. Their portfolio also covers bone wires, trochar wires, and surgical guides like the ACCU-CUT™ Z GUIDE and MTP-FUSION reamer. Some products are reusable, while others are sterile or non-sterile.
The company’s devices fall under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. Biopro, Inc. is based in the United States.
Catalogue
Search and filter all 3,018 devicesShowing 1-50 of 3,018
Company details
- FDA FEI number
- 1832656
- DUNS number
- 618749857
- Address
- 2929 Lapeer Rd, PORT HURON, MI, 48060
FDA recalls
FDA recall records list 39 recalls initiated by BIOPRO, INC., the earliest on 2011-09-21 and the most recent on 2025-09-09. By recorded status: 6 ongoing and 33 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. 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 21
- 2020 0
- 2021 0
- 2022 10
- 2023 0
- 2024 0
- 2025 6
- 2026 0
2025
- 9 Sep 2025 Z-0148-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- 9 Sep 2025 Z-0149-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- 9 Sep 2025 Z-0150-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- 9 Sep 2025 Z-0151-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- 9 Sep 2025 Z-0152-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- 9 Sep 2025 Z-0153-2026 Class II Ongoing Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
2022
- 1 Feb 2022 Z-0682-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0683-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0684-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0685-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Show the 25 most recent of 39 recalls
2022
- 1 Feb 2022 Z-0686-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0687-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0688-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0689-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0690-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
- 1 Feb 2022 Z-0691-2022 Class II Terminated There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
2019
- 25 Jun 2019 Z-2239-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2240-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2241-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2242-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2243-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2244-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2245-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2246-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2247-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
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- 25 Jun 2019 Z-2239-2019 Class II Terminated Manufacturing flaw in the sterile barrier system
Frequently asked questions
How many devices does BIOPRO, INC. have in the registry?
The registry currently lists 3018 devices for BIOPRO, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOPRO, INC.'s devices?
Among its 50 most recently registered devices, BIOPRO, INC. has devices listed in 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 BIOPRO, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for BIOPRO, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for BIOPRO, INC.?
FDA recall records list 39 recalls initiated by BIOPRO, INC., the most recent initiated on 9 Sep 2025. 6 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 BIOPRO, INC. in the registry?
The most recently registered devices listed for BIOPRO, INC. include Rose Dorsal Plate 23292, Rose Proximal Cutting Guide 23294, Rose Plantar Plate 23293 and Rose Distal Cutting Guide 23295.