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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 44 of 61

Device	Model / Reference	Registries	Class	Status
11mm Fusion Nail, Left	21408	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 10 Hole, right, Sterile	21174	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 100mm, Sterile	21336	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 30mm Sterile	21074	FDA UDI	Class II	Active
Locking Drill Guide 3.5mm solid	20919	FDA UDI	Class I	Active
Insert Providence 10 Deg 28x58	15087	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 26mm Sterile	21780	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 8mm	20568	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 30mm	20862	FDA UDI	Class II	Active
Cortical Screw, 3.5mm x 38mm	21736	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 50mm	20845	FDA UDI	Class II	Active
Thumb Tmc Pc Sm 13	15094	FDA UDI	Class II	Active
Drill Guide 3 Leg 18x16	18304	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm X 34mm	21522	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 30mm	17110	FDA UDI	Class II	Active
K-wire .030" x 4" Double Trochar	18682	FDA UDI	Class II	Active
Medial 3 Column Plate, short, right Sterile	21052	FDA UDI	Class II	Active
14mm X 3.0 Hbs Screw Sdst	20323	FDA UDI	Class II	Active
6.5 x 115mm Go-EZ Screw	19671	FDA UDI	Class II	Active
Insert Cc 28x48	10065	FDA UDI	Class II	Active
Hbs Screw 2.5 X 20mm Sdst	20505	FDA UDI	Class II	Active
3.0 x 14mm HBS Screw	19570	FDA UDI	Class II	Active
Hbs (sterile) Complete Kit	19686	FDA UDI	Class I	Active
Memory Staple 11 X 17 X 151.5 X 1.5mm	17635	FDA UDI	Class II	Active
4.5 x 38mm Go-EZ Screw	19034	FDA UDI	Class II	Active
3.5 x 14mm Go-EZ Screw	18207	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 4mm, left Sterile	20951	FDA UDI	Class II	Active
Horizon Titanium Subtalar 12mm	17225	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +6	19007	FDA UDI	Class II	Active
Goez Screw 6.5 X 80mm	19664	FDA UDI	Class II	Active
Small Staple Drill, Sterile	17751	FDA UDI	Class I	Active
9mm Nail Cap + 5mm	21636	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 34mm	21555	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 85mm, Sterile	21333	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 26mm, Sterile	21252	FDA UDI	Class II	Active
Fibula Plate 3 Hole, left Sterile	21090	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 12mm Sterile	20596	FDA UDI	Class II	Active
Clover Staple 3 Leg 14mm x 12mm x 12.5mm	18069	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 28mm	20566	FDA UDI	Class II	Active
Goez Screw 4.0 X 32mm	19041	FDA UDI	Class II	Active
BioPro	22919	FDA UDI	Class II	Active
28mm X 2.5 Hbs Screw Sdst Pkg	20509	FDA UDI	Class II	Active
Insert Total Mod 24x74	10384	FDA UDI	Class II	Active
ORIF Calc Plate, medium Sterile	21059	FDA UDI	Class II	Active
Goez Screw 2.0 X 28mm	19266	FDA UDI	Class II	Active
Insert Total Mod 13x66	10357	FDA UDI	Class II	Active
Accu-Cut™ Two Stage W/2 Blades	17506	FDA UDI	Class I	Active
Fasciotome Short 1.57	20279	FDA UDI	Class I	Active
Insert Total 13x70	10269	FDA UDI	Class II	Active
10mm X 3.0 Hbs Screw Sdst	20321	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.