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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 20 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Locking Screw 4.0mm x 50mm Sterile	21078	FDA UDI	Class II	Active
TOE NON POROUS COATED MEDIUM 20mm	10061	FDA UDI	Class II	Active
Cortical Screw, Low Head, 3.5mm x 34mm	21730	FDA UDI	Class II	Active
K-Wire Sterile 1.4mmx300mm Dbl Trocar	22828	FDA UDI	Class II	Active
Straight Fracture Plate 6 holes 2.5/2.8mm	20616	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 12 Hole, left, Sterile	21163	FDA UDI	Class II	Active
Biopro Memory Staple 15x15-1.5x1.5mm Pkg	22775	FDA UDI	Class II	Active
Head Trial 15MM+2	17267	FDA UDI	Class I	Active
Sizer 9MM	17186	FDA UDI	Class I	Active
2.0 x 12mm Go-EZ Screw	18165	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 45mm	20844	FDA UDI	Class II	Active
Posterior Tibia Plate 2 Hole	21149	FDA UDI	Class II	Active
Insert Total Mod 20x70	10376	FDA UDI	Class II	Active
11mm Nail Cap + 5mm	21627	FDA UDI	Class II	Active
5 Mm Bone Screw X 22 Mm	21612	FDA UDI	Class II	Active
10mm Fusion Nail, Left	21347	FDA UDI	Class II	Active
Staple Positioner 18x16	19514	FDA UDI	Class I	Active
ORIF Standard Calc Plate, medium Sterile	21062	FDA UDI	Class II	Active
HBS SCREW 3.0 x 12mm S.C. PKG	20414	FDA UDI	Class II	Active
Insert Uni Comp Sm 10.0	14135	FDA UDI	Class II	Active
Uni Lm/Rl Lg	10302	FDA UDI	Class II	Active
Insert Total Mod 8 X 86	10338	FDA UDI	Class II	Active
Toe Joint Titanium Npc Lg 23mm	16816	FDA UDI	Class II	Active
Insert Total Mod 10x78	10347	FDA UDI	Class II	Active
Evans Plate 10mm, Left Sterile	21039	FDA UDI	Class II	Active
Tara Femoral Component 38	10085	FDA UDI	Class II	Active
Tray Mod 74	10328	FDA UDI	Class II	Active
Toe Joint Titanium Pc Sm 17mm	17035	FDA UDI	Class II	Active
Insert Uni Lg 11.5	10311	FDA UDI	Class II	Active
Kwire, Single Trocar, 1.0 X 80mm	OL108010	FDA UDI	Class II	Active
3.0 x 24mm HBS Screw	19580	FDA UDI	Class II	Active
Stem Pc Lg 3	10122	FDA UDI	Class II	Active
Mtp Fusion Plate, Narrow 10 Degree, Left	23083	FDA UDI	Class II	Active
3.5 x 24mm Go-EZ Screw	18212	FDA UDI	Class II	Active
THUMB MOD HEAD 14mm +2	17240	FDA UDI	Class II	Active
Goez Screw 6.5 X 30mm	19651	FDA UDI	Class II	Active
Stem Pc Xshort 4	17045	FDA UDI	Class II	Active
2.5 x 18mm HBS Screw	19553	FDA UDI	Class II	Active
Insert Uni Md 6.5	10309	FDA UDI	Class II	Active
Clover Staple 4 Leg 10mm x 8mm x 10mm	18259	FDA UDI	Class II	Active
Knee Rt 86	10245	FDA UDI	Class II	Active
Stem Pc Sh 7	10136	FDA UDI	Class II	Active
Osteotome, Curved Lambotte, 13mm	3365113	FDA UDI	Class I	Active
Thumb Mod Head Titanium 13mm+4	20235	FDA UDI	Class II	Active
Hbs Screw 2.5 X 40mm Sdst	20515	FDA UDI	Class II	Active
Hex Driver 3.0 3.5	18324	FDA UDI	Class I	Active
MVA Cortical Locking Screw, 3, 0mm x 22mm Sterile	20781	FDA UDI	Class II	Active
Curved Guide Wire Ss	22384	FDA UDI	Class II	Active
Mtp Fusion Plate, Narrow 5 Degree, Right	23086	FDA UDI	Class II	Active
Thumb Tmc Pc Md 16	15096	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.