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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 53 of 61

Device	Model / Reference	Registries	Class	Status
Hbs Screw 2.5 X 16mm Sdst	20503	FDA UDI	Class II	Active
Goez Screw 6.5 X 55mm	19659	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/70mm	16592	FDA UDI	Class II	Active
BioPro	22861	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 13 MM	21708	FDA UDI	Class I	Active
Stem Npc Sh 11	11583	FDA UDI	Class II	Active
Small Staple Punch	17654	FDA UDI	Class I	Active
3.0 x 10mm Go-EZ Screw	18187	FDA UDI	Class II	Active
3.0 x 18mm Go-EZ Screw	18191	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 5 Hole, right	21165	FDA UDI	Class II	Active
BioPro Bipolar Head 45mm	18137	FDA UDI	Class II	Active
TOE JOINT NPC 10.25mm W/HOLE	17327	FDA UDI	Class II	Active
Hbs Screw 2.5 X 34mm S. C. Pkg	20409	FDA UDI	Class II	Active
Medial Distal Column Plate, short	20909	FDA UDI	Class II	Active
MVA Cortical Locking screw 2.0mm x 20mm	20477	FDA UDI	Class II	Active
SMALL STAPLE 9x7	17629	FDA UDI	Class II	Active
SM staple 4 3/4 Bulldog Hemostat	17651	FDA UDI	Class I	Active
T-Handle	22811	FDA UDI	Class I	Active
Horizon Hybrid Subtalar 11mm	17088	FDA UDI	Class II	Active
Goez Screw 3.5 X 16mm	18208	FDA UDI	Class II	Active
9mm STEP STAPLE 15X20-2X2	17716	FDA UDI	Class II	Active
Accucut Guide Dmaa Right Pkg	19721	FDA UDI	Class I	Active
THUMB MOD HEAD 13mm	17005	FDA UDI	Class II	Active
25mm x 3 HBS High Comp - S. C.	19198	FDA UDI	Class II	Active
Stem Broach 8.5MM	19461	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 26mm Sterile	21001	FDA UDI	Class II	Active
Cortical Locking Screw, 4.0mm x 36mm Sterile	21719	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 30mm Sterile	21003	FDA UDI	Class II	Active
Tendon Anchor System Driver Shaft	20079	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 20mm	21274	FDA UDI	Class II	Active
5 Mm Bone Screw X 28 Mm	21615	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 12mm Implant	22648	FDA UDI	Class II	Active
Toe Hemi Edge PC SM	19815	FDA UDI	Class II	Active
Goez Screw 2.5 X 40mm	19254	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 9mm	22645	FDA UDI	Class II	Active
Uni Lm/Rl Xlg	10303	FDA UDI	Class II	Active
Goez Screw 3.0 X 20mm	18192	FDA UDI	Class II	Active
Impactor Tip Lg	15257	FDA UDI	Class I	Active
Insert Cc 28x67	10073	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 80mm, Sterile	21264	FDA UDI	Class II	Active
Horizon Titanium Subtalar 9mm	17222	FDA UDI	Class II	Active
SCREW D.C. 1.8 x 50mm	17120	FDA UDI	Class II	Active
Medial 4 Column Plate, short, right	20900	FDA UDI	Class II	Active
4.5 x 12mm Go-EZ Screw	18242	FDA UDI	Class II	Active
Burr Adaptor-Microaire	17351	FDA UDI	Class I	Active
2.0 x 24mm Go-EZ Screw	18171	FDA UDI	Class II	Active
Clover Staple 3 Leg 10 X 8 X 10	18262	FDA UDI	Class II	Active
3.5 x 50mm Go-EZ Screw	18225	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 3 Hole, Sterile	21188	FDA UDI	Class II	Active
11mm Fusion Nail, Right	21351	FDA UDI	Class II	Active

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Importers

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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.