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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 10 of 61

Device	Model / Reference	Registries	Class	Status
Insert Uni Comp Lg 8.5	14140	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 9.5 MM	22387	FDA UDI	Class I	Active
MTP Fusion Plate SM-13 Left Sterile	21496	FDA UDI	Class II	Active
Head Trial 12MM+2	17264	FDA UDI	Class I	Active
Cannulated Drill Sterile 4.04.5mm	19236	FDA UDI	Class I	Active
K-Wire with stop 1.0mm	20666	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.0mm x 18mm Sterile	20585	FDA UDI	Class II	Active
Knee Rt 66	10240	FDA UDI	Class II	Active
Pusher 4 Leg 10x8	18299	FDA UDI	Class I	Active
2.5 x 48mm Go-EZ Screw	19258	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/35mm	16585	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 8mm	22644	FDA UDI	Class II	Active
3.5 x 40mm Go-EZ Screw	18220	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Pc Md 20mm	10413	FDA UDI	Class II	Active
Double Drill Guide 2.0-2.5mm Screws	20643	FDA UDI	Class I	Active
First Mpj Hemi Complete Kit	17368	FDA UDI	Class I	Active
Lateral Suture Anchor, PEEK 4.5mm x 20mm	L-4520	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 10mm Sterile	20993	FDA UDI	Class II	Active
Insert Total Mod 13x62	10356	FDA UDI	Class II	Active
Insert Total 16x66	10275	FDA UDI	Class II	Active
Endo Sh 51	10194	FDA UDI	Class II	Active
BioPro Bipolar Head 46mm	18138	FDA UDI	Class II	Active
Kwire single trocar 1.6 x 280mm, Sterile	OL28016S	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 0mm, right	20751	FDA UDI	Class II	Active
Insert Providence 10 Deg 28x46	15081	FDA UDI	Class II	Active
32mm X 3 Hbs Std Comp - S. C.	19215	FDA UDI	Class II	Active
Insert Providence 28x46	15125	FDA UDI	Class II	Active
6" Bone Clamp	18337	FDA UDI	Class I	Active
28mm X 3.0 Hbs Screw Sdst Pkg	20525	FDA UDI	Class II	Active
3.0 x 15mm HBS Screw	19571	FDA UDI	Class II	Active
2.0 x 30mm Go-EZ Screw	19267	FDA UDI	Class II	Active
Large Staple Punch	17653	FDA UDI	Class I	Active
Impactor Tip (Straight)	17387	FDA UDI	Class I	Active
Toe Joint Titanium Npc Lg 23mm	16816	FDA UDI	Class II	Active
Hbs Screw 3.0 X 30mm Sdst	20526	FDA UDI	Class II	Active
BioPro Bipolar Head 47mm	18139	FDA UDI	Class II	Active
L-Shaped Fracture Plate 6 holes, right Sterile	20792	FDA UDI	Class II	Active
THUMB MOD STEM 8.5mm	17066	FDA UDI	Class II	Active
Tara Femoral Component 49	10090	FDA UDI	Class II	Active
BioPro Bipolar Head 52mm	18144	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 38mm sterile	21564	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 100mm	21293	FDA UDI	Class II	Active
Open Wedge Plate 3mm Sterile	20726	FDA UDI	Class II	Active
Tara Femoral Component 45	10088	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 100mm	21243	FDA UDI	Class II	Active
38mm X 2.5 Hbs Screw Sdst Pkg	20514	FDA UDI	Class II	Active
18mm x 2.5 HBS Sd Comp	19359	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 49	13011	FDA UDI	Class II	Active
Goez Screw 4.0 X 14mm	18230	FDA UDI	Class II	Active
13mm Fusion Nail, Left	21594	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.