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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 47 of 61

Device	Model / Reference	Registries	Class	Status
10mm Nail Cap + 5mm	21626	FDA UDI	Class II	Active
Endo Sh 38	10188	FDA UDI	Class II	Active
Medial 3 Column Plate, long, right Sterile	21054	FDA UDI	Class II	Active
Insert Total Mod 13x86	10362	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 34 mm	21510	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 22mm Sterile	20700	FDA UDI	Class II	Active
Drill Screw Sleeve	21388	FDA UDI	Class I	Active
Bending Iron left	20664	FDA UDI	Class I	Active
Goez Screw 2.5 X 14mm	18176	FDA UDI	Class II	Active
5 Mm Bone Screw X 78 Mm	21609	FDA UDI	Class II	Active
Toe Joint Titanium Npc Md 20mm	16814	FDA UDI	Class II	Active
Goez Screw 2.0 X 36mm	19270	FDA UDI	Class II	Active
4.5 x 50mm Go-EZ Screw	19040	FDA UDI	Class II	Active
36mm X 3.0 Hbs Screw Sdst Pkg	20529	FDA UDI	Class II	Active
Large Staple Drill, Sterile	17753	FDA UDI	Class I	Active
Cutting Guide Handle	19399	FDA UDI	Class I	Active
Cortical Screw, Low Head 3.5mm x 75mm, Sterile	21313	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 45mm	21232	FDA UDI	Class II	Active
Insert Cc 32x65	10081	FDA UDI	Class II	Active
12mm x 2.5 HBS High Comp	19374	FDA UDI	Class II	Active
12mm X 2.5 Hbs Screw Sdst	20306	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 13.5 MM	22395	FDA UDI	Class I	Active
32mm X 3.0 Hbs Std Ft Pkg	22551	FDA UDI	Class II	Active
Depth Gauge 3.0/3.5/4.0 – 60mm	21339	FDA UDI	Class I	Active
Screw Bone 6.5/40	10728	FDA UDI	Class II	Active
Endo Sh 55	10196	FDA UDI	Class II	Active
5 Mm Bone Screw X 66 Mm	21370	FDA UDI	Class II	Active
MTP Fusion Plate SM-8 Left Sterile	21500	FDA UDI	Class II	Active
Medial Distal Column Plate, long Sterile	21056	FDA UDI	Class II	Active
5 Mm Bone Screw X 24 Mm	21603	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 10mm	20550	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 12mm	21220	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 24mm	20800	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 95mm	21213	FDA UDI	Class II	Active
Insert Cc 28x69	10074	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 80mm, Sterile	21314	FDA UDI	Class II	Active
11mm Fusion Nail, Right	21411	FDA UDI	Class II	Active
Straight Fracture Plate 4 Holes 2mm Sterile	20601	FDA UDI	Class II	Active
Medial Tibia Plate 8 Hole, left Sterile	21125	FDA UDI	Class II	Active
30mm X 2.5 Hbs Screw Sdst	20315	FDA UDI	Class II	Active
Knee Rt 82	10244	FDA UDI	Class II	Active
Insert Providence 32x52	15076	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 38 mm sterile	21519	FDA UDI	Class II	Active
5 Mm Bone Screw X 40 Mm	21357	FDA UDI	Class II	Active
Fibula Plate 6 Hole, left	21087	FDA UDI	Class II	Active
T-Shape Fracture Plate, 3 Holes Sterile	21210	FDA UDI	Class II	Active
Stem Pc Sh 1	10130	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 11.00mm	16821	FDA UDI	Class II	Active
Tara Femoral Component 43	10087	FDA UDI	Class II	Active
Insert Total 12x70	15008	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.