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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 18 of 61

Device	Model / Reference	Registries	Class	Status
HBS SCREW 3.0 x 38mm S.C. PKG	20427	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Pc Sm 17mm	10412	FDA UDI	Class II	Active
Insert Total 12x62	15004	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 4 Hole, Sterile	21189	FDA UDI	Class II	Active
Accu-Cut™ 3mm	19508	FDA UDI	Class I	Active
Medial TMT I Fusion Plate	20756	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes, left	20871	FDA UDI	Class II	Active
Horizon Subtalar Complete Kit	17307	FDA UDI	Class I	Active
Evans Plate 10mm, right	20895	FDA UDI	Class II	Active
Goez Screw 4.5 X 20mm	18246	FDA UDI	Class II	Active
Goez Screw 6.5 X 38mm	19655	FDA UDI	Class II	Active
2.5 x 42mm Go-EZ Screw	19255	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 38mm	21546	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 28mm	20861	FDA UDI	Class II	Active
24mm X 3.0 Hbs Std Ft	22579	FDA UDI	Class II	Active
MTP Fusion Plate MD-13 Left	21489	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 16 MM	21711	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 12mm, Sterile	21245	FDA UDI	Class II	Active
Insert Uni Comp Md 10.0	14138	FDA UDI	Class II	Active
Osteotome, Curved, 8mm	95-8008C	FDA UDI	Class I	Active
Goez Screw 6.5 X 115mm	19671	FDA UDI	Class II	Active
Goez Screw 4.5 X 14mm	18243	FDA UDI	Class II	Active
2.5 x 26mm Go-EZ Screw	18182	FDA UDI	Class II	Active
Mod Thumb Oscillating Burr Fine 14mm	17372	FDA UDI	Class I	Active
Goez Screw 6.5 X 60mm	19660	FDA UDI	Class II	Active
3.5 x 10mm Go-EZ Screw	18205	FDA UDI	Class II	Active
12mm Nail Cap	21621	FDA UDI	Class II	Active
Steinmann Pin Single Trocar Round 12" 2.4MM	21674	FDA UDI	Class II	Active
24mm X 2.5 Hbs Screw Sdst Pkg	20507	FDA UDI	Class II	Active
2.8MM Foot Plating System Tray	22995	FDA UDI	Class II	Unknown
Insert Providence 10 Deg 28x54	15086	FDA UDI	Class II	Active
20mm X 2.5 Hbs Screw Sdst	20310	FDA UDI	Class II	Active
10mm X 3.0 Hbs Std Ft	22572	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 0mm, right Sterile	20952	FDA UDI	Class II	Active
Goez Screw 2.0 X 50mm	19277	FDA UDI	Class II	Active
Stem Pc Xshort 6	17047	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Sizing Probe 12mm	22661	FDA UDI	Class I	Active
TOE POROUS COATED MEDIUM SMALL 18.5mm	17034	FDA UDI	Class II	Active
Double Drill Guide 2.8-3.0mm Screws	20922	FDA UDI	Class I	Active
15mm Nail Cap	21624	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 80mm	21239	FDA UDI	Class II	Active
Lesser Mpj Trial 9.50mm	16965	FDA UDI	Class I	Active
4.0 x 18mm Go-EZ Screw	18232	FDA UDI	Class II	Active
Tendon Anchor System Wire	20078	FDA UDI	Class II	Active
K-WIRE .045" 2PT 4" Long	16863	FDA UDI	Class II	Active
5 Mm Bone Screw X 62 Mm	21368	FDA UDI	Class II	Active
Insert Total Mod 12x86	15044	FDA UDI	Class II	Active
Straight Fracture Plate 3 Holes 2mm	21207	FDA UDI	Class II	Active
Rod Tibial Medullary 12x150	10353	FDA UDI	Class II	Active
Horizon Titanium Subtalar 12mm	17225	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.