Biopro, Inc.
2929 Lapeer Rd, PORT HURON, MI, US
Registered product codes
45 product codes
Recent MDR events
34 on file
- BIOPRO MODULAR THUMB IMPLANTMay 4, 2026InjuryMW5187631
- GO-EZ SCREWDec 21, 2022Injury1832656-2022-00001
- BIOPRO PSL HIP STEMJun 30, 2020Injury1832656-2020-00004
- BIOPRO IMPLANT RIGHT HALLUX AND LONG ARM AUSTIN WITH INTERNAL FIXATION RIGHT FOONov 30, 2018InjuryMW5081760
- DIGITAL COMPRESSION SCREWNov 8, 20161832656-2016-00003
- GO-EZAug 9, 2016Malfunction1832656-2016-00001
- BIOPRO PSL HIP STEMOct 26, 2015Malfunction1832656-2015-00001
- BIOPRO GO-EZ SCREWJun 25, 2014Injury1833506-2014-00002
- BIOPRO GREAT TOE MP JOINTMay 15, 2014Injury1833506-2014-00001
- BIOPRO MEMORY STAPLEOct 15, 2012Malfunction1833506-2012-00003
Recalls
39 on file
- Open, ClassifiedOct 14, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 14, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 14, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 14, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 14, 2025
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.
View FDA record ↗ - Open, ClassifiedOct 14, 2025
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.
View FDA record ↗ - TerminatedNov 4, 2011
BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
View FDA record ↗ - TerminatedNov 4, 2011
BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗ - TerminatedUnknown
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.
View FDA record ↗
Compliance history
Matched by FEI 1832656.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.