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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 33 of 61

Device	Model / Reference	Registries	Class	Status
Cortical Screw 2.8mm X 35 mm sterile	21517	FDA UDI	Class II	Active
Insert Total Mod 14x70	15037	FDA UDI	Class II	Active
3.0 x 36mm Go-EZ Screw	18200	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 10mm, Sterile	21294	FDA UDI	Class II	Active
Open Wedge Plate 4mm Sterile	20727	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Npc M/S 18.5mm	17033	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 14mm	21271	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 30mm Sterile	20704	FDA UDI	Class II	Active
Locking Drill Guide 4.0mm solid	20920	FDA UDI	Class I	Active
Straight Low Contact Locking Plate 4 Hole, Sterile	21139	FDA UDI	Class II	Active
ORIF Calc Plate, short Sterile	21058	FDA UDI	Class II	Active
26mm X 3.0 Hbs Screw Sdst	20329	FDA UDI	Class II	Active
Goez Screw 2.5 X 30mm	18184	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 11.75mm	16822	FDA UDI	Class II	Active
5 Mm Bone Screw X 70 Mm	21372	FDA UDI	Class II	Active
Apollo Labral Anchor, Peek 3.5mm x 13mm	S-3213	FDA UDI	Class II	Active
Insert Total 16x82	10279	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 28mm	20840	FDA UDI	Class II	Active
Toe Joint Titanium Pc M/L 21.5mm	17037	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 28mm	20813	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 38mm	21534	FDA UDI	Class II	Active
Insert Total 8x86	10259	FDA UDI	Class II	Active
26mm X 2.5 Hbs Screw Sdst Pkg	20508	FDA UDI	Class II	Active
Tray Total 74	10249	FDA UDI	Class II	Active
Fibula Plate 3 Hole, left	21085	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 26mm Sterile	20702	FDA UDI	Class II	Active
6.5 x 55mm Go-EZ Screw	19659	FDA UDI	Class II	Active
Medial 3 Column Plate, short, left Sterile	21053	FDA UDI	Class II	Active
Insert Total 16x86	10280	FDA UDI	Class II	Active
Pusher 4 Leg 10x8	18299	FDA UDI	Class I	Active
Distraction/Compression Device	20938	FDA UDI	Class I	Active
Memory Staple 9 X 71.5 X 1.5mm/Sm	17629	FDA UDI	Class II	Active
SCREW D.C. 1.5 x 20mm	17201	FDA UDI	Class II	Active
Straight Fusion Plate 4 holes Sterile	20787	FDA UDI	Class II	Active
4.0 x 12mm Go-EZ Screw	18229	FDA UDI	Class II	Active
Insert Total Mod 13x78	10360	FDA UDI	Class II	Active
12mm STEP STAPLE 15X20-2X2	17717	FDA UDI	Class II	Active
Goez Screw 2.0 X 24mm	18171	FDA UDI	Class II	Active
Straight Entry Awl	21665	FDA UDI	Class I	Active
Stem Pc Sh 9	10138	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 45mm	20828	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 1mm, left	20747	FDA UDI	Class II	Active
kwire single trocar 1.4 x 150mm, Sterile	OL15014S	FDA UDI	Class II	Active
Template 14.0mm/Square	16976	FDA UDI	Class I	Active
Drill Guide	18656	FDA UDI	Class I	Active
22mm X 2.5 Hbs Screw Sdst	20311	FDA UDI	Class II	Active
Hex Driver 4.0 4.5	18325	FDA UDI	Class I	Active
Mtp Fusion Plate 5 Degree, Right	23080	FDA UDI	Class II	Active
Toe Porous Coated W/Hole Ms	17746	FDA UDI	Class II	Active
Biopro	22934	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.