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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 4 of 61

Device	Model / Reference	Registries	Class	Status
MVA Cortical Locking Screw 3.0mm x 20mm	20798	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 6 Hole, left	21154	FDA UDI	Class II	Active
HBS SCREW 3.0 x 34mm S.C. PKG	20425	FDA UDI	Class II	Active
Thumb Mod Head Titanium 14mm+4	20236	FDA UDI	Class II	Active
Insert Cc 32x53	10076	FDA UDI	Class II	Active
Toe Joint Titanium Pc Lg 23mm	17038	FDA UDI	Class II	Active
Insert Total 16x70	10276	FDA UDI	Class II	Active
Template 8.00mm/8.75mm	16972	FDA UDI	Class I	Active
Hbs Screw 2.5 X 10mm Sdst	20500	FDA UDI	Class II	Active
Horizon Titanium Subtalar 10mm	17223	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 14mm Sterile	20597	FDA UDI	Class II	Active
2.0 Screw-Plate Module	22926	FDA UDI	Class II	Active
Endo Modular Ceramic Md 55	14826	FDA UDI	Class II	Active
BioPro Bipolar Head 55mm	18147	FDA UDI	Class II	Active
Goez Screw 2.0 X 8mm	18163	FDA UDI	Class II	Active
TOE JOINT NPC 13.25mm W/HOLE	17331	FDA UDI	Class II	Active
Drill Guide Single Hole	19467	FDA UDI	Class I	Active
Clover Staple 3 Leg 18mm x 16mm x 15mm	18073	FDA UDI	Class II	Active
MEDIUM STAPLE 15x12	17625	FDA UDI	Class II	Active
HEAD FEMORAL 32mm +18	19137	FDA UDI	Class II	Active
6.5 x 120mm Go-EZ Screw	19672	FDA UDI	Class II	Active
Screw Bone 6.5/30	10726	FDA UDI	Class II	Active
HEAD FEMORAL 32mm +6	19134	FDA UDI	Class II	Active
Insert Cc 32x58	10078	FDA UDI	Class II	Active
26mm X 2.5 Hbs Std Comp-S.c.	19338	FDA UDI	Class II	Active
XSMALL STAPLE 7x5	17637	FDA UDI	Class II	Active
14mm Fusion Nail, Right	21591	FDA UDI	Class II	Active
2.5 x 20mm HBS Screw	19555	FDA UDI	Class II	Active
Osteotome, Bevelled, 5mm X 400mm	95-7556	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 14.5 MM	22398	FDA UDI	Class I	Active
Accu-Cut™ Std Micro Choice	17721	FDA UDI	Class I	Active
Head Trial 12MM+4	17613	FDA UDI	Class I	Active
Round Carbide Burr 4.0MM	18276	FDA UDI	Class I	Active
ACCU-CUT™ 1 mm MICRO CHOICE	17733	FDA UDI	Class I	Active
Mtp Fusion Plate, Narrow 5 Degree, Left	23085	FDA UDI	Class II	Active
Pusher 3 Leg 10x8	118311	FDA UDI	Class I	Active
THUMB MOD HEAD 13mm +4	17501	FDA UDI	Class II	Active
Burr Guide 4 Leg 14x12	18297	FDA UDI	Class I	Active
Sizer 8MM	17185	FDA UDI	Class I	Active
Insert Total 24x62	10288	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 10mm	20815	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 9 MM	21694	FDA UDI	Class I	Active
Goez Screw 2.0 X 6mm	18162	FDA UDI	Class II	Active
L-Shaped Fracture Plate 6 holes, left	20872	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 10mm	20852	FDA UDI	Class II	Active
Cortical Screw, Low Head, 3.5mm x 36mm Sterile	21727	FDA UDI	Class II	Active
Toe Joint Titanium Pc Lg 23mm	17038	FDA UDI	Class II	Active
Pusher 3 Leg 18x16	18313	FDA UDI	Class I	Active
Horizon Titanium Subtalar 9mm	17222	FDA UDI	Class II	Active
Goez Screw 3.5 X 36mm	18218	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.