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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 48 of 61

Device	Model / Reference	Registries	Class	Status
2.5 x 22mm HBS Screw	19557	FDA UDI	Class II	Active
Angled Staple Punch	17655	FDA UDI	Class I	Active
Goez Screw 3.0 X 22mm	18193	FDA UDI	Class II	Active
Cannulated Drill 4.04.5mm	19142	FDA UDI	Class I	Active
Clover Staple 3 Leg 18mm x 16mm x 10mm	18071	FDA UDI	Class II	Active
Y-Shape Fracture Plate 3 Holes 2mm	21203	FDA UDI	Class II	Active
Kwire double trocar 1.2 x 150mm, Sterile	OL15012DS	FDA UDI	Class II	Active
Accu-Cut™ Two Stage Synthese	19536	FDA UDI	Class I	Active
Hbs Drill Collet Assembly Sterile	19683	FDA UDI	Class I	Active
Dorsal TMT I Fusion Plate 1mm, right Sterile	20953	FDA UDI	Class II	Active
Toe Joint Titanium Pc Md 20mm	17036	FDA UDI	Class II	Active
Cortical Locking Screw, 4.0mm x 32mm Sterile	21717	FDA UDI	Class II	Active
Thumb Tmc Md 13mm	14265	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 36mm	21545	FDA UDI	Class II	Active
Goez Screw 2.5 X 8mm	18173	FDA UDI	Class II	Active
Insert Cc 26 X 50	11797	FDA UDI	Class II	Active
Guide Wire, 2.5 X 200mm	33.022.5200	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3.5mm x 32mm	21686	FDA UDI	Class II	Active
Cortical Locking Screw, 4.0mm x 32mm	21721	FDA UDI	Class II	Active
ORIF Calc Plate, medium	20911	FDA UDI	Class II	Active
THUMB MOD HEAD 12mm +2	17238	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 10mm Sterile	20694	FDA UDI	Class II	Active
Large Staple Punch	17653	FDA UDI	Class I	Active
Cortical Locking Screw 4.0mm x 22mm Sterile	21070	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 40mm Sterile	21016	FDA UDI	Class II	Active
MPJ TRIAL 20mm (MD)	12236	FDA UDI	Class I	Active
Burr Guide 3 Leg 10x8	18308	FDA UDI	Class I	Active
6.5 x 70mm Go-EZ Screw	19662	FDA UDI	Class II	Active
2.5 x 38mm Go-EZ Screw	19253	FDA UDI	Class II	Active
18mm X 2.5 Hbs Std Comp-S.c.	19334	FDA UDI	Class II	Active
Open Wedge Plate 6mm Sterile	20729	FDA UDI	Class II	Active
Cortical Locking Screw, 3.5mm x 34mm Sterile	21762	FDA UDI	Class II	Active
Goez Screw 4. 5 X 50mm	19040	FDA UDI	Class II	Active
20mm X 3.0 Hbs Std Ft Pkg	22545	FDA UDI	Class II	Active
Drill Guide 4 Leg 14x12	18291	FDA UDI	Class I	Active
K-WIRE 0.9X70MM SNG TROCAR Non Sterile	22831	FDA UDI	Class II	Active
Kwire single trocar 1.0 x 230mm, Sterile	OL23010S	FDA UDI	Class II	Active
Y-Shape Fracture Plate 3 holes 2.5/2.8mm	20618	FDA UDI	Class II	Active
Insert Total 14x70	15009	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 80mm Sterile	21084	FDA UDI	Class II	Active
16mm X 3.0 Hbs Std Ft	22575	FDA UDI	Class II	Active
HBS SCREW 3.0 x 36mm S.C. PKG	20426	FDA UDI	Class II	Active
30mm X 3.0 Hbs Std Ft	22582	FDA UDI	Class II	Active
X-Plate Large	20881	FDA UDI	Class II	Active
1.8x150mm Double Trocar	OL15018DS	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 30mm Sterile	21014	FDA UDI	Class II	Active
Stem Pc Lg 4	10123	FDA UDI	Class II	Active
L-Shape Fracture Plate, 3 hole, RIGHT, Sterile	21200	FDA UDI	Class II	Active
2.0 x 20mm Go-EZ Screw	18169	FDA UDI	Class II	Active
Toe Joint Titanium Pc Ms 18.5mm	17197	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.