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BIOPRO, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 19 of 61

Device	Model / Reference	Registries	Class	Status
TOE JOINT SM 10.0mmX13.5mm	17376	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 36	17295	FDA UDI	Class II	Active
Osteotome, Curved, 4mm	95-4004C	FDA UDI	Class I	Active
BioPro Bipolar Head 39mm	18131	FDA UDI	Class II	Active
40mm X 3.0 Hbs Std Ft	22587	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 70mm	20849	FDA UDI	Class II	Active
Toe Joint Titanium Pc Md 20mm	17036	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 90mm, Sterile	21334	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 28mm, Sterile	21253	FDA UDI	Class II	Active
Straight Fracture Plate 8 holes 2mm	20605	FDA UDI	Class II	Active
Insert Total 12x86	15016	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 90mm	21325	FDA UDI	Class II	Active
Memory Staple 7 X 51.5 X 1.5mm/Sm	17628	FDA UDI	Class II	Active
Goez Screw 3.5 X 48mm	18224	FDA UDI	Class II	Active
Burr Fine 13MM	19759	FDA UDI	Class I	Active
14mm X 3 Hbs Std Comp - S. C.	19206	FDA UDI	Class II	Active
Medial Suture Anchor, PEEK 4.5mm x 15mm	M-4515	FDA UDI	Class II	Active
Hbs Screw 2.5 X 18mm S. C. Pkg	20401	FDA UDI	Class II	Active
4.5 x 10mm Go-EZ Screw	18241	FDA UDI	Class II	Active
3.0 x 29mm HBS Screw	19585	FDA UDI	Class II	Active
3.5 x 28mm Go-EZ Screw	18214	FDA UDI	Class II	Active
15mm Nail Cap + 5mm	21631	FDA UDI	Class II	Active
Thumb Tmc Sm 14.5mm	14262	FDA UDI	Class II	Active
14mm Nail Cap + 5mm	21641	FDA UDI	Class II	Active
Kwire single trocar 2.0 x 230mm, Sterile	OL23020S	FDA UDI	Class II	Active
Memory Staple 20 X 202 X 2mm/Md	17627	FDA UDI	Class II	Active
Insert Providence 28x48	15126	FDA UDI	Class II	Active
Thumb Tmc Lg 16mm	14272	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 12mm	20480	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 5 Hole, Sterile	21140	FDA UDI	Class II	Active
Hbs Screw 2.5 X 38mm S. C. Pkg	20411	FDA UDI	Class II	Active
28mm X 3.0 Hbs Screw Sdst	20330	FDA UDI	Class II	Active
Evans Plate 6mm, left Sterile	21037	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 14mm Sterile	21066	FDA UDI	Class II	Active
Hbs Screw 2.5 X 30mm Sdst	20510	FDA UDI	Class II	Active
Drill Bit – Ao – Qc, 2.0mm, Blue, 115mm Lgth.	22680	FDA UDI	Class I	Active
11mm Nail Cap	21381	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 18mm	21273	FDA UDI	Class II	Active
20mm x 3 HBS High Comp - S. C.	19193	FDA UDI	Class II	Active
Endo Modular Ceramic Md 36	17296	FDA UDI	Class II	Active
Ratchet Handle With Ao Connect	22293	FDA UDI	Class I	Active
Sizer 11MM	17188	FDA UDI	Class I	Active
MTP Fusion revision Plate Right	20613	FDA UDI	Class II	Active
36mm X 3 Hbs Std Comp - S. C.	19217	FDA UDI	Class II	Active
Horixon Subtalar Gen 2 Instrument tray	22652	FDA UDI	Class I	Active
Evans Plate 10mm, left	20891	FDA UDI	Class II	Active
Burr Coarse 12MM	19532	FDA UDI	Class I	Active
Goez Screw 3.0 X 6mm	18185	FDA UDI	Class II	Active
Ratcheting Handle	18664	FDA UDI	Class I	Active
HEAD FEMORAL 28mm -3	19004	FDA UDI	Class II	Active

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FDA Recalls (39)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 9, 2025	Z-0148-2026	—	open, classified	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.
Sep 9, 2025	Z-0149-2026	—	open, classified	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.
Sep 9, 2025	Z-0151-2026	—	open, classified	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.
Sep 9, 2025	Z-0153-2026	—	open, classified	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.
Sep 9, 2025	Z-0150-2026	—	open, classified	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.
Sep 9, 2025	Z-0152-2026	—	open, classified	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.
Feb 1, 2022	Z-0684-2022	—	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.
Feb 1, 2022	Z-0683-2022	—	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.
Feb 1, 2022	Z-0686-2022	—	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.
Feb 1, 2022	Z-0685-2022	—	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.
Feb 1, 2022	Z-0688-2022	—	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.
Feb 1, 2022	Z-0691-2022	—	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.
Feb 1, 2022	Z-0690-2022	—	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.
Feb 1, 2022	Z-0687-2022	—	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.
Feb 1, 2022	Z-0689-2022	—	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.
Feb 1, 2022	Z-0682-2022	—	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.
Jun 25, 2019	Z-2256-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2249-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2253-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2241-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2254-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2243-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2244-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2257-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2252-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2259-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2239-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2250-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2255-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2258-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2248-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2251-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2246-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2242-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2245-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2240-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2247-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Sep 21, 2011	Z-0164-2012	—	terminated	BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
Sep 21, 2011	Z-0163-2012	—	terminated	BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.