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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 28 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw 2.8mm X 38 mm	21513	FDA UDI	Class II	Active
Uni Lm/Rl Md	10301	FDA UDI	Class II	Active
Knee Lt 78	10220	FDA UDI	Class II	Active
Medial 4 Column Plate, long, left Sterile	21051	FDA UDI	Class II	Active
5 Mm Bone Screw X 26 Mm	21604	FDA UDI	Class II	Active
5 Mm Bone Screw X 48 Mm	21361	FDA UDI	Class II	Active
3.0 x 17mm HBS Screw	19573	FDA UDI	Class II	Active
5 Mm Bone Screw X 26 Mm	21614	FDA UDI	Class II	Active
5 Mm Bone Screw X 68 Mm	21371	FDA UDI	Class II	Active
Drill Guide 11 - 13MM	17649	FDA UDI	Class I	Active
Goez Screw 2.5 X 42mm	19255	FDA UDI	Class II	Active
3.0 x 28mm Go-EZ Screw	18196	FDA UDI	Class II	Active
Goez Screw 4.0 X 38mm	19044	FDA UDI	Class II	Active
16mm X 2.5 Hbs Screw Sdst	20308	FDA UDI	Class II	Active
Goez/Hbs Complete Kit	22288	FDA UDI	Class I	Active
20mm X 3.0 Hbs Screw Sdst	20326	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 55mm Sterile	21035	FDA UDI	Class II	Active
Insert Total Mod 10x62	10343	FDA UDI	Class II	Active
Endo Sh 43	10190	FDA UDI	Class II	Active
Rod Tibial Medullary 12x50	10352	FDA UDI	Class II	Active
K-Wire with Stop 1.2 x 150mm Long	21341	FDA UDI	Class II	Active
Accu-Cut™ Two Stage	19509	FDA UDI	Class I	Active
Kwire single trocar 1.1 x 150mm, Sterile	OL15011S	FDA UDI	Class II	Active
Cannulated Drill Sterile 2.02.5mm	19234	FDA UDI	Class I	Active
12mm X 2.5 Hbs Std Comp-S.c.	19331	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 11 MM	21696	FDA UDI	Class I	Active
MVA Cortical Locking Screw 2.8mm x 20mm Sterile	20687	FDA UDI	Class II	Active
Depth Gauge	18880	FDA UDI	Class I	Active
32mm X 2.5 Hbs Std Comp-S.c.	19341	FDA UDI	Class II	Active
Staple 4 Leg 10x8x15	18261	FDA UDI	Class II	Active
Mod Thumb Oscillating Burr Fine 12mm	17370	FDA UDI	Class I	Active
Straight Fracture Plate 3 Holes 2mm Sterile	21208	FDA UDI	Class II	Active
ACCU-CUT™ 3mm OFFSET W/2 BLADES	17505	FDA UDI	Class I	Active
Insert Cc 32x75/81	10084	FDA UDI	Class II	Active
MTP Fusion Plate Right	20611	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 35mm, Sterile	21255	FDA UDI	Class II	Active
Screw Bone 6.5/25	10725	FDA UDI	Class II	Active
Sizing Guide 14MM	19808	FDA UDI	Class I	Active
HEMI EDGE™ TOE SMALL 17mm	19538	FDA UDI	Class II	Active
2.5 x 18mm Go-EZ Screw	18178	FDA UDI	Class II	Active
3.0 x 21mm HBS Screw	19577	FDA UDI	Class II	Active
Goez Screw 4.0 X 42mm	19046	FDA UDI	Class II	Active
Sizing Guide 13MM	19807	FDA UDI	Class I	Active
MPJ TRIAL 18.5mm (MS)	17180	FDA UDI	Class I	Active
Cortical Bone Screw 4.5/30mm	16584	FDA UDI	Class II	Active
4.0 x 48mm Go-EZ Screw	19049	FDA UDI	Class II	Active
2.5 x 11mm HBS Screw	19546	FDA UDI	Class II	Active
38mm X 3.0 Hbs Std Ft	22586	FDA UDI	Class II	Active
Rectangular Plate L Sterile	20966	FDA UDI	Class II	Active
Effi+pro Pin 2..6mm Coil	20199	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.