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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 49 of 61

Device	Model / Reference	Registries	Class	Status
MVA Cortical Locking Screw 3.5mm x 24mm Sterile	21011	FDA UDI	Class II	Active
10mm HBS® Standard Compression	18608	FDA UDI	Class II	Active
2.5 x 44mm Go-EZ Screw	19256	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3.5mm x 38mm	21689	FDA UDI	Class II	Active
Straight Fusion Plate 4 holes	20869	FDA UDI	Class II	Active
5 Mm Bone Screw X 60 Mm	21427	FDA UDI	Class II	Active
9mm Fusion Nail, Left	21346	FDA UDI	Class II	Active
Goez Screw 2.0 X 46mm	19275	FDA UDI	Class II	Active
Goez Screw 3.0 X 30mm	18197	FDA UDI	Class II	Active
Hbs Screw 2.5 X 28mm Sdst	20509	FDA UDI	Class II	Active
Fibula Plate 4 Hole, left	21086	FDA UDI	Class II	Active
T-Shape Fracture Plate 3 Holes 2.5/2.8mm	20624	FDA UDI	Class II	Active
Insert Total Mod 14x66	15035	FDA UDI	Class II	Active
BioPro Bipolar Head 57mm	18149	FDA UDI	Class II	Active
20mm x 2.5 HBS Sd Comp	19361	FDA UDI	Class II	Active
Accu-Cut™ Long Arm	19510	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 80mm	21323	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 9 Hole	21134	FDA UDI	Class II	Active
Stem Npc Lg 11	11568	FDA UDI	Class II	Active
Head Femoral 32 Lg Lt	14096	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 16mm	21222	FDA UDI	Class II	Active
BioPro	22863	FDA UDI	Class I	Active
Hbs Screw 3.0 X 10mm Sdst	20516	FDA UDI	Class II	Active
Burr Guide 4 Leg 18x16	18298	FDA UDI	Class I	Active
17mm x 2.5 HBS Sd Comp	19358	FDA UDI	Class II	Active
Thumb Mod Head Titanium 14mm	17806	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 75mm	21238	FDA UDI	Class II	Active
Insert Total Mod 16x62	10367	FDA UDI	Class II	Active
15mm Fusion Nail, Left	21596	FDA UDI	Class II	Active
Goez Screw 3.0 X 18mm	18191	FDA UDI	Class II	Active
Cannulated Drill Sterile 3.03.5mm	19235	FDA UDI	Class I	Active
14mm X 2.5 Hbs Std Comp-S.c.	19332	FDA UDI	Class II	Active
L-Shaped Fracture Plate 6 holes, right	20874	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 10mm	20793	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 38mm	21768	FDA UDI	Class II	Active
22mm X 3.0 Hbs Std Ft	22578	FDA UDI	Class II	Active
T-Shape Fracture Plate, 4 Holes	20877	FDA UDI	Class II	Active
Goez Screw 2.5 X 36mm	19252	FDA UDI	Class II	Active
ORIF Standard Calc plate, short	20913	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 6mm Implant	22642	FDA UDI	Class I	Unknown
Hbs Screw 3.0 X 24mm Sdst	20523	FDA UDI	Class II	Active
5 Mm Bone Screw X 50 Mm	21362	FDA UDI	Class II	Active
Screw Bone 6.5/20	10724	FDA UDI	Class II	Active
Staple 3 Leg 10x8x10	18262	FDA UDI	Class II	Active
2.5 x 14mm Go-EZ Screw	18176	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/60mm	16590	FDA UDI	Class II	Active
Goez Screw 2.5 X 6mm	18172	FDA UDI	Class II	Active
11mm x 2.5 HBS High Comp	19373	FDA UDI	Class II	Active
Lesser Mpj Trial 11.75mm	16968	FDA UDI	Class I	Active
Rectangular Plate S Sterile	20964	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.