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BIOPRO, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 52 of 61

Device	Model / Reference	Registries	Class	Status
Cannulated Drill Sterile 2.0-2.5MM	19234	FDA UDI	Class I	Active
Cortical Screw 3.5mm x 34mm Sterile	21772	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 10 Hole, Sterile	21195	FDA UDI	Class II	Active
Goez Screw 6.5 X 105mm	19669	FDA UDI	Class II	Active
MD Staple Drill, Sterile	17752	FDA UDI	Class I	Active
Toe Joint Cobalt Chrome Pc M/L 21.5mm	14960	FDA UDI	Class II	Active
5 Mm Bone Screw X 54 Mm	21364	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 18mm	20483	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 40mm	21281	FDA UDI	Class II	Active
Y-Shape Fracture Plate 3 holes 2.5/2.8mm Sterile	20714	FDA UDI	Class II	Active
Y-Shape Fracture Plate 4 holes 2mm	20606	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 24mm	20822	FDA UDI	Class II	Active
K-wire 0.9" x 70mm Single Trochar	18685	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 26mm Sterile	21072	FDA UDI	Class II	Active
20mm X 2.5 Hbs Screw Sdst Pkg	20505	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 22mm	21742	FDA UDI	Class II	Active
Mtp Fusion Plate 0 Degree, Right	23082	FDA UDI	Class II	Active
Medial 3 Column Plate, short, left	20905	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 7 Hole, Sterile	21192	FDA UDI	Class II	Active
Stem Pc Sh 10	10139	FDA UDI	Class II	Active
Goez Screw 3.5 X 8mm	18204	FDA UDI	Class II	Active
5 Mm Bone Screw X 30 Mm	21352	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 40 mm	21514	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 35 mm	21511	FDA UDI	Class II	Active
3.0 x 26mm Go-EZ Screw	18195	FDA UDI	Class II	Active
Cortical Screw 2.0mm x 12mm Sterile	20589	FDA UDI	Class II	Active
K-Wire 4" X.035" .500 M1.0 Thread	19091	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 50mm	20866	FDA UDI	Class II	Active
Insert Providence 10 Deg 28x54	15085	FDA UDI	Class II	Active
Toe Joint Npc Sm W/Bevel	16626	FDA UDI	Class II	Active
Horizon Hybrid Subtalar 8mm	17085	FDA UDI	Class II	Active
Trial 8MM	17190	FDA UDI	Class I	Active
HEAD FEMORAL CERAMIC 32mm +3	19027	FDA UDI	Class II	Active
BioPro Bipolar Head 44mm	18136	FDA UDI	Class II	Active
Thumb Tmc Pc Md 14.5	15095	FDA UDI	Class II	Active
Kwire, Single Trocar, 2.0 X 150mm	OL15020S	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes, right Sterile	20791	FDA UDI	Class II	Active
SCREW D.C. 1.8 x 45mm	17119	FDA UDI	Class II	Active
Drill Bit AO QC 2.5mm / 150mm length	20926	FDA UDI	Class I	Active
MTP Fusion Plate MD-8 Left	21493	FDA UDI	Class II	Active
Toe Joint Npc Sm W/Bevel	20185	FDA UDI	Class II	Active
3.0 x 38mm Go-EZ Screw	18201	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 25mm	17202	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 35mm	17111	FDA UDI	Class II	Active
16mm X 3 Hbs Std Comp - S. C.	19207	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 9.50mm	16819	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 6 Hole, Sterile	21141	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 14mm	20795	FDA UDI	Class II	Active
Head Trial 15MM+4	17616	FDA UDI	Class I	Active
Mod Thumb Oscillating Burr Fine 15mm	17373	FDA UDI	Class I	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.