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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 1 of 61

Device	Model / Reference	Registries	Class	Status
Goez Screw 2.0 X 20mm	18169	FDA UDI	Class II	Active
BioPro	22918	FDA UDI	Class II	Active
Pin Guide	17523	FDA UDI	Class I	Active
MTP-FUSION REAMER, convex Ø12mm	20675	FDA UDI	Class I	Active
Accu-Cut™ Z Guide	19511	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 80mm	21289	FDA UDI	Class II	Active
4" Non Threaded Sngl Trochar Wire .035	18330	FDA UDI	Class II	Active
3.5 x 30mm Go-EZ Screw	18215	FDA UDI	Class II	Active
HEAD FEMORAL CERAMIC 32mm -3	19025	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 20mm	20574	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 14mm	20817	FDA UDI	Class II	Active
Memory Staple Instrument Tray	17708	FDA UDI	Class I	Active
3.0 x 11mm HBS Screw	19567	FDA UDI	Class II	Active
30mm x 3 HBS High Comp - S. C.	19203	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 60mm	21285	FDA UDI	Class II	Active
Locking Drill Guide 2.5mm	20637	FDA UDI	Class I	Active
Insert Providence 28x54	15129	FDA UDI	Class II	Active
MTP Fusion Revision Plate Left Sterile	20708	FDA UDI	Class II	Active
Insert Total Mod 12x74	15038	FDA UDI	Class II	Active
Stem Pc Xshort 2	17043	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 20mm Sterile	21069	FDA UDI	Class II	Active
Goez Screw 3.5 X 10mm	18205	FDA UDI	Class II	Active
4.0 x 32mm Go-EZ Screw	19041	FDA UDI	Class II	Active
4.0 x 16mm Go-EZ Screw	18231	FDA UDI	Class II	Active
Medial Tibia Plate 4 Hole, left	21117	FDA UDI	Class II	Active
14mm X 2.5 Hbs Screw Sdst	20307	FDA UDI	Class II	Active
Patella Poly 44	10317	FDA UDI	Class II	Active
Evans Plate 10mm, right Sterile	21043	FDA UDI	Class II	Active
28mm X 2.5 Hbs Screw Sdst	20314	FDA UDI	Class II	Active
16mm X 2.5 Hbs Screw Sdst Pkg	20503	FDA UDI	Class II	Active
Osteotome, Curved, 10mm	95-1010C	FDA UDI	Class I	Active
6.5 x 90mm Go-EZ Screw	19666	FDA UDI	Class II	Active
Bone Cement Gouge, Outside Bevelled, 10MM x 310MM	95-7180	FDA UDI	Class I	Active
Drill Guide 3 Leg 10x8	18302	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm X 40mm	21535	FDA UDI	Class II	Active
Open Wedge Plate 2mm Sterile	20725	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 16mm	20482	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 9 Hole	21184	FDA UDI	Class II	Active
Effi+pro Pin 2.4mm/4.5	20195	FDA UDI	Class I	Active
VA Drill Guide 3.0mm Screws	20921	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 32mm	21542	FDA UDI	Class II	Active
10mm Nail Cap	21380	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 12mm	20570	FDA UDI	Class II	Active
10mm X 3.0 Hbs Screw Sdst Pkg	20516	FDA UDI	Class II	Active
BioPro Bipolar Head 50mm	18142	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 18mm	20835	FDA UDI	Class II	Active
Insert Uni Comp Lg 10.0	14141	FDA UDI	Class II	Active
2.0 x 26mm Go-EZ Screw	19265	FDA UDI	Class II	Active
Insert Cc 26 X 48	11796	FDA UDI	Class II	Active
19mm x 2.5 HBS Sd Comp	19360	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.