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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 36 of 61

Device	Model / Reference	Registries	Class	Status
HBS SCREW 3.0 x 32mm S.C. PKG	20424	FDA UDI	Class II	Active
2.0 x 28mm Go-EZ Screw	19266	FDA UDI	Class II	Active
Thumb Mod Head Titanium 15mm	17808	FDA UDI	Class II	Active
Insert Total Mod 16x66	10368	FDA UDI	Class II	Active
Endo Sh 45	10191	FDA UDI	Class II	Active
Holding and Bending Pins 2.0	20662	FDA UDI	Class I	Active
Cortical Screw 3.0mm x 12mm Sterile	20994	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 40mm, Sterile	21256	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 16mm Sterile	21067	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 14.00mm	16870	FDA UDI	Class II	Active
Insert Total Mod 20x78	10378	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 24mm	21226	FDA UDI	Class II	Active
Insert Total 24x82	10293	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 26mm	20801	FDA UDI	Class II	Active
Screw Bone 6.5/50	10730	FDA UDI	Class II	Active
Fibula Plate 6 Hole, right Sterile	21102	FDA UDI	Class II	Active
Biopro Curved Trochar	22684	FDA UDI	Class I	Active
Depth Gauge 3.5 4.5	19736	FDA UDI	Class I	Active
BioPro	20969	FDA UDI	Class II	Active
Goez Screw 2.5 X 24mm	18181	FDA UDI	Class II	Active
Cloverleaf Plate, 3 hole	21201	FDA UDI	Class II	Active
Hbs Screw 2.5 X 36mm S. C. Pkg	20410	FDA UDI	Class II	Active
Quick Connect Handle	19125	FDA UDI	Class I	Active
2.5 x 19mm HBS Screw	19554	FDA UDI	Class II	Active
Drill Guide Adjustable	17681	FDA UDI	Class I	Active
Clover Staple 4 Leg 10mm x 8mm x 12.5 mm	18260	FDA UDI	Class II	Active
24mm x 2.5 HBS Sd Comp	19365	FDA UDI	Class II	Active
30mm X 3 Hbs Std Comp - S. C.	19214	FDA UDI	Class II	Active
Hex Driver 6.5	19751	FDA UDI	Class I	Active
Insert Providence 10 Deg 28x50	15083	FDA UDI	Class II	Active
36mm X 3.0 Hbs Std Ft	22585	FDA UDI	Class II	Active
Rectangular Plate M Sterile	20965	FDA UDI	Class II	Active
Cotton Plate 6 mm	20884	FDA UDI	Class II	Active
Drill Bit AO QC 3.0mm / 150mm length	20928	FDA UDI	Class I	Active
Dorsal TMT I Fusion Plate 3mm, left	20749	FDA UDI	Class II	Active
Thumb Tmc Md 19mm	14269	FDA UDI	Class II	Active
3.0 x 14mm HBS Screw	19570	FDA UDI	Class II	Active
BioPro Bipolar Head 41mm	18133	FDA UDI	Class II	Active
Hbs 3.0mm Screw 2.4mm Drill Sterile	19682	FDA UDI	Class I	Active
Endo Sh 41	10189	FDA UDI	Class II	Active
Hbs Ft Relief Drill 1.0	22522	FDA UDI	Class I	Active
Dwyer Plate 10mm Sterile	21047	FDA UDI	Class II	Active
36mm X 2.5 Hbs Screw Sdst	20318	FDA UDI	Class II	Active
K-Wire 1.1x150mm Dbl Trocar Raw	22827	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 28mm Sterile	21073	FDA UDI	Class II	Active
Posterior Tibia Plate 4 Hole, Sterile	21152	FDA UDI	Class II	Active
Dwyer Plate 8mm Sterile	21046	FDA UDI	Class II	Active
Medial Tibial Plate 4 Hole, right	21105	FDA UDI	Class II	Active
TOE POROUS COATED MEDIUM 20mm	10413	FDA UDI	Class II	Active
Hbs Screw 3.0 X 16mm Sdst	20519	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.