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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 30 of 61

Device	Model / Reference	Registries	Class	Status
MVA Cortical Locking Screw 3.0mm x 16mm	20796	FDA UDI	Class II	Active
X-Plate Small Sterile	20958	FDA UDI	Class II	Active
38mm X 3 Hbs Std Comp - S. C.	19218	FDA UDI	Class II	Active
Impactor Tip SM	15256	FDA UDI	Class I	Active
Goez Screw 3.5 X 34mm	18217	FDA UDI	Class II	Active
Tray Uni Lg	10322	FDA UDI	Class II	Active
Locking Drill Guide, 3.5mm	20918	FDA UDI	Class I	Active
Sizing Guide 12MM	19806	FDA UDI	Class I	Active
Stem Pc Sh 4	10133	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 70mm Sterile	21082	FDA UDI	Class II	Active
K-wire .062" x 4" Double Trochar	17232	FDA UDI	Class II	Active
Tray Mod 78	10329	FDA UDI	Class II	Active
Insert Cc 28x44	10063	FDA UDI	Class II	Active
K-Wire Sterile Double Trochar .035	19283	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 Sizing Probe 8mm	22657	FDA UDI	Class I	Active
Cortical Bone Screw 4.5/25mm	16583	FDA UDI	Class II	Active
2.5 x 28mm Go-EZ Screw	18183	FDA UDI	Class II	Active
Pusher 3 Leg 14x12	18312	FDA UDI	Class I	Active
3.0 x 14mm Go-EZ Screw	18189	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 35mm	21556	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 20mm Sterile	21009	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 55mm	17115	FDA UDI	Class II	Active
L-Shaped Fracture Plate 3 holes, left 2.5/2.8mm Sterile	20716	FDA UDI	Class II	Active
TOE JOINT NPC 12.5mm	16868	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 6 Hole	21131	FDA UDI	Class II	Active
32mm X 3.0 Hbs Screw Sdst Pkg	20527	FDA UDI	Class II	Active
Thumb Mod Head Titanium 14mm+2	17807	FDA UDI	Class II	Active
Kwire Threaded Sterile Single Trochar .035	19107	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 24mm Sterile	21027	FDA UDI	Class II	Active
Medial Tibial Plate 10 Hole, right	21108	FDA UDI	Class II	Active
2.5 x 12mm Go-EZ Screw	18175	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm x 24mm Sterile	20689	FDA UDI	Class II	Active
Goez Screw 3.0 X 8mm	18186	FDA UDI	Class II	Active
Distraction Spreader	20937	FDA UDI	Class I	Active
2.5 x 12mm HBS Screw	19547	FDA UDI	Class II	Active
Insert Total 10x66	10261	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 36mm Sterile	21773	FDA UDI	Class II	Active
Stem Trial 7.5MM	17345	FDA UDI	Class I	Active
Screw Pick Up 3.5 6.5	18335	FDA UDI	Class I	Active
2.5 x 17mm HBS Screw	19552	FDA UDI	Class II	Active
24mm X 2.5 Hbs Screw Sdst	20312	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 35mm Sterile	21031	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 24mm	21746	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 16mm Sterile	21007	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 40mm sterile	21565	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 4mm, right	20755	FDA UDI	Class II	Active
26mm HBS® High Compression	18645	FDA UDI	Class II	Active
K-Wire 1.4x300mm Dbl Trocar Raw	22829	FDA UDI	Class II	Active
Round Carbide Burr 6.5MM	18278	FDA UDI	Class I	Active
Lateral Suture Anchor, PEEK 6.5mm x 20mm	L-6520	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.