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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 14 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Locking Screw 3.5mm x 12mm	20853	FDA UDI	Class II	Active
Cortical Screw, 3.5mm x 34mm	21734	FDA UDI	Class II	Active
Goez Screw 2.5 X 16mm	18177	FDA UDI	Class II	Active
K-Wire Sterile 1.4mmx150mm Dbl Trocar	22823	FDA UDI	Class II	Active
Stem Trial 10.0MM	17347	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 10 MM	21397	FDA UDI	Class I	Active
Cortical Screw 2.5mm x 16mm Sterile	20658	FDA UDI	Class II	Active
Thumb Mod Head Titaniium 12mm	17780	FDA UDI	Class II	Active
Goez Screw 4.5 X 32mm	19031	FDA UDI	Class II	Active
Subtalar Pin Guide Gen II	23014	FDA UDI	Class I	Active
Chisel	15112	FDA UDI	Class I	Active
Cannulated Drill 3.03.5mm	18333	FDA UDI	Class I	Active
HBS SCREW 2.5 x 16mm S.C. PKG	20400	FDA UDI	Class II	Active
15mm Nail Cap + 5mm	21642	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 18mm, Sterile	21298	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 14mm	20552	FDA UDI	Class II	Active
SMALL STAPLE 11x8	17630	FDA UDI	Class II	Active
Dwyer Plate 6mm Sterile	21045	FDA UDI	Class II	Active
Drill Guide Single Hole	17656	FDA UDI	Class I	Active
Hbs Screw 2.5 X 22mm Sdst	20506	FDA UDI	Class II	Active
2.5 x 50mm Go-EZ Screw	19259	FDA UDI	Class II	Active
Kwire double trocar 1.1 x 100mm, Sterile	OL10011DS	FDA UDI	Class II	Active
Knee Lt 82	10221	FDA UDI	Class II	Active
Y-Shape Fracture Plate 6 holes 2mm Sterile	20667	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.0mm x 20mm Sterile	20586	FDA UDI	Class II	Active
Insert Providence 32x56	15078	FDA UDI	Class II	Active
3.0 x 12mm Go-EZ Screw	18188	FDA UDI	Class II	Active
Burr Guide 4 Leg 10x8	18296	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 40mm	21231	FDA UDI	Class II	Active
Drill Guide 4 Leg 18x16	18292	FDA UDI	Class I	Active
Insert Cc 32x63	10080	FDA UDI	Class II	Active
Goez Screw 2.0 X 38mm	19271	FDA UDI	Class II	Active
2.5 x 26mm HBS Screw	19561	FDA UDI	Class II	Active
Head Trial 14MM	17262	FDA UDI	Class I	Active
Subtalar Gen 2 QR Handle 3/16 Black	22854	FDA UDI	Class I	Active
Toe Hemi Edge PC MS	19816	FDA UDI	Class II	Active
Template 9.50mm/10.25mm	16973	FDA UDI	Class I	Active
Hbs Screw 3.0 X 14mm Sdst	20518	FDA UDI	Class II	Active
HEAD FEMORAL 32mm -3	19131	FDA UDI	Class II	Active
3.0 x 22mm Go-EZ Screw	18193	FDA UDI	Class II	Active
Memory Staple Complete Kit	17707	FDA UDI	Class I	Active
Bone Spatula	17383	FDA UDI	Class I	Active
3.5 x 26mm Go-EZ Screw	18213	FDA UDI	Class II	Active
30mm X 3.0 Hbs Std Ft Pkg	22550	FDA UDI	Class II	Active
SMALL STAPLE 15x12	17633	FDA UDI	Class II	Active
Osteotome, Bone Cement, Bevelled, 310mm X 5mm	95-7553	FDA UDI	Class I	Active
Dorsal TMT I Fusion Plate 0mm, left Sterile	20947	FDA UDI	Class II	Active
Drill Guide 4 Leg 14x12	18291	FDA UDI	Class I	Active
20mm X 3 Hbs Std Comp - S. C.	19209	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 8 MM	21693	FDA UDI	Class I	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.