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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 39 of 61

Device	Model / Reference	Registries	Class	Status
Kwire double trocar 2.0 x 100mm, Sterile	OL20010DS	FDA UDI	Class II	Active
Crimping Tool	22666	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.5mm x 22mm sterile	21775	FDA UDI	Class II	Active
THUMB MOD HEAD 13mm +2	17239	FDA UDI	Class II	Active
Cutting Guide	20063	FDA UDI	Class I	Active
Cortical Screw 2.8mm x 12mm Sterile	20695	FDA UDI	Class II	Active
Drill Sleeve	21657	FDA UDI	Class I	Active
14mm Fusion Nail, Left	21587	FDA UDI	Class II	Active
3.0-3.5 Plate Module	22931	FDA UDI	Class II	Active
4.0 x 36mm Go-EZ Screw	19043	FDA UDI	Class II	Active
MPJ Trial 18.5mm (MS)	17180	FDA UDI	Class I	Active
Horizon Subtalar Gen 2 Hex Driver	22653	FDA UDI	Class I	Active
2.5 x 29mm HBS Screw	19564	FDA UDI	Class II	Active
Clover Staple 4 Leg 18 X 16 X 10	18065	FDA UDI	Class II	Active
5 Mm Bone Screw X 22 Mm	21602	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 20mm, Sterile	21249	FDA UDI	Class II	Active
28mm x 3 HBS High Comp - S. C.	19201	FDA UDI	Class II	Active
Insert Total Mod 16x74	10370	FDA UDI	Class II	Active
Endo Md 38	10179	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 32mm Sterile	21771	FDA UDI	Class II	Active
Kwire double trocar 1.6 x 100mm, Sterile	OL10016DS	FDA UDI	Class II	Active
Goez Screw 3.0 X 40mm	18202	FDA UDI	Class II	Active
Thumb Tmc Sm 16mm	14263	FDA UDI	Class II	Active
Knee Lt 74	10219	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 75mm, Sterile	21331	FDA UDI	Class II	Active
Y-Shape Fracture Plate 4 holes 2mm Sterile	20652	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 18mm	20490	FDA UDI	Class II	Active
Stem Pc Sh 11	11580	FDA UDI	Class II	Active
3.0 x 6mm Go-EZ Screw	18185	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 65mm, Sterile	21311	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 35mm	21230	FDA UDI	Class II	Active
Hbs Kwire Sterile	19688	FDA UDI	Class II	Active
Toe Non Porous Coated W/Hole Md	17742	FDA UDI	Class II	Active
Drill Staple Medium (2.4mm)	17661	FDA UDI	Class I	Active
Anterior Lateral Tibia Plate 12 Hole, right	21169	FDA UDI	Class II	Active
Impactor Tip Sm	15256	FDA UDI	Class I	Active
Insert Total 14x66	15007	FDA UDI	Class II	Active
HBS SCREW 2.5 x 24mm S.C. PKG	20404	FDA UDI	Class II	Active
Mod Thumb Oscillating Burr Coarse 15mm	17344	FDA UDI	Class I	Active
Holding and Bending Pins 2.5 – 2.8mm	20663	FDA UDI	Class I	Active
Evans Plate 6mm, right Sterile	21041	FDA UDI	Class II	Active
Go Ez Screw Unpkg 2x50	19877	FDA UDI	Class II	Active
3.5 x 20mm Go-EZ Screw	18210	FDA UDI	Class II	Active
Osteotome, 18mm	95-1818	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 14mm	20854	FDA UDI	Class II	Active
BioPro	20972	FDA UDI	Class II	Active
Knee Rt 70	10241	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 14 Hole, right, Sterile	21176	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.0mm x 16mm Sterile	20584	FDA UDI	Class II	Active
Toe Non Porous Coated W/Hole Ms	17741	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.