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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 32 of 61

Device	Model / Reference	Registries	Class	Status
Tray Total 82	10251	FDA UDI	Class II	Active
Sizing Guide 15MM	19809	FDA UDI	Class I	Active
3.0 x 28mm HBS Screw	19584	FDA UDI	Class II	Active
MTP-FUSION REAMER, convex Ø16mm	20677	FDA UDI	Class I	Active
1.2x310mm Single Trocar	OL31012S	FDA UDI	Class II	Active
5-Star Template	17309	FDA UDI	Class I	Active
Goez Screw 6.5 X 100mm	19668	FDA UDI	Class II	Active
K-Wire Sterile Single Trochar .045	19108	FDA UDI	Class II	Active
X-Plate Medium Sterile	20959	FDA UDI	Class II	Active
Lesser Mpj Trial 11.0mm	16967	FDA UDI	Class I	Active
MTP Fusion Plate SM-8 Right Sterile	21499	FDA UDI	Class II	Active
2.5-2.8 Screw Module	22927	FDA UDI	Class II	Active
Burr Fine 15MM	19761	FDA UDI	Class I	Active
3.0 x 16mm HBS Screw	19572	FDA UDI	Class II	Active
Thumb Tmc Pc Lg 17.5	15097	FDA UDI	Class II	Active
Dwyer Plate 8mm	20898	FDA UDI	Class II	Active
21mm x 3 HBS High Comp - S. C.	19194	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 10mm	22646	FDA UDI	Class II	Active
3.0 x 34mm Go-EZ Screw	18199	FDA UDI	Class II	Active
Depth Gauge	18378	FDA UDI	Class I	Active
Dwyer Plate 10mm	20899	FDA UDI	Class II	Active
Evans Plate 4mm, right	20892	FDA UDI	Class II	Active
Goez Screw 4.0 X 34mm	19042	FDA UDI	Class II	Active
3.0 x 10mm HBS Screw	19566	FDA UDI	Class II	Active
4.5 x 22mm Go-EZ Screw	18247	FDA UDI	Class II	Active
HEAD FEMORAL 36mm +9	19057	FDA UDI	Class II	Active
Clover Staple 3 Leg 10 X 8 X 12.5	18263	FDA UDI	Class II	Active
Drill Guide, Left	21645	FDA UDI	Class I	Active
4.5 x 42mm Go-EZ Screw	19036	FDA UDI	Class II	Active
MTP-FUSION REAMER, convex Ø14mm	20676	FDA UDI	Class I	Active
2.0 x 6mm Go-EZ Screw	18162	FDA UDI	Class II	Active
HEAD FEMORAL 36mm -3	19053	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 16mm, Sterile	21297	FDA UDI	Class II	Active
Drill Screw Sleeve	21655	FDA UDI	Class I	Active
12mm Nail Cap + 5mm	21628	FDA UDI	Class II	Active
Stem Npc Sh 12	11584	FDA UDI	Class II	Active
4.5 x 36mm Go-EZ Screw	19033	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 3mm, right	20754	FDA UDI	Class II	Active
Locking Drill Guide 3.0mm	20639	FDA UDI	Class I	Active
Stem Pc Lg 13	11567	FDA UDI	Class II	Active
13mm x 3 HBS High Comp - S. C.	19186	FDA UDI	Class II	Active
Thumb Mod Head Titanium 15mm+2	17809	FDA UDI	Class II	Active
Drill Guide 7 9mm	17648	FDA UDI	Class I	Active
2.0 x 44mm Go-EZ Screw	19274	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 18mm Sterile	20698	FDA UDI	Class II	Active
HEMI EDGE™ TOE MEDIUM LARGE 21.5mm	19541	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 34mm sterile	21537	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 60mm, Sterile	21328	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 26mm	20812	FDA UDI	Class II	Active
5 Mm Bone Screw X 36 Mm	21355	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Authorities

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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.