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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 23 of 61

Device	Model / Reference	Registries	Class	Status
TOE JOINT NPC 11.75mm W/HOLE	17329	FDA UDI	Class II	Active
Lateral Suture Anchor, PEEK 5.5mm x 20mm	L-5520	FDA UDI	Class II	Active
Splitting Chisel, 10MM x 310MM	95-7545	FDA UDI	Class I	Active
Guide Wire Subtalar 12	17606	FDA UDI	Class II	Active
Impactor Handle	15259	FDA UDI	Class I	Active
Rectangular Plate M	20886	FDA UDI	Class II	Active
MTP Fusion Plate MD-13 Right Sterile	21497	FDA UDI	Class II	Active
Goez Screw 4.5 X 26mm	18249	FDA UDI	Class II	Active
Staple 4 Leg 18x16x10	18065	FDA UDI	Class II	Active
BioPro Bipolar Head 54mm	18146	FDA UDI	Class II	Active
Drill bit AO QC 1.5 x 85/60mm, Sterile	OL15DBS	FDA UDI	Class I	Active
4.5 x 30mm Go-EZ Screw	18251	FDA UDI	Class II	Active
THUMB MOD STEM TITANIUM TPS 11.5mm	17603	FDA UDI	Class II	Active
Kwire Sterile Single Trochar .045	19108	FDA UDI	Class II	Active
Trial Punch	16980	FDA UDI	Class I	Active
Burr Cutter	18315	FDA UDI	Class I	Active
Staple 3 Leg 18x16x12.5	18072	FDA UDI	Class II	Active
2.5 x 34mm Go-EZ Screw	19251	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3.5mm x 36mm Sterile	21684	FDA UDI	Class II	Active
MVA Cortical Locking Screw, 3.5mm x 34mm	21687	FDA UDI	Class II	Active
Lesser Mpj Trial 10.25mm	16966	FDA UDI	Class I	Active
Goez Screw 4.5 X 44mm	19037	FDA UDI	Class II	Active
T-Shape Fracture Plate 6 holes 2mm	20609	FDA UDI	Class II	Active
Endo Md 55	10187	FDA UDI	Class II	Active
Cortical Locking Screw, 4.0mm x 38mm Sterile	21720	FDA UDI	Class II	Active
Medial Tibia Plate 4 Hole, left Sterile	21123	FDA UDI	Class II	Active
Clover Staple Drill Bit 1.5MM x 18MM	18960	FDA UDI	Class I	Active
Toe Joint Mpj 2nd5th 8.00mm	16818	FDA UDI	Class II	Active
Tray Uni Xlg	10323	FDA UDI	Class II	Active
Medial 3 Column Plate, long, left Sterile	21055	FDA UDI	Class II	Active
6.5 x 85mm Go-EZ Screw	19665	FDA UDI	Class II	Active
18mm X 2.5 Hbs Screw Sdst	20309	FDA UDI	Class II	Active
Medial Tibia Plate 8 Hole, left	21119	FDA UDI	Class II	Active
Insert Total Mod 10x74	10346	FDA UDI	Class II	Active
Curved Trocar Assy	21668	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 11 MM	21398	FDA UDI	Class I	Active
ACCU-CUT™ 2mm OFFSET W/2 BLADES	17504	FDA UDI	Class I	Active
3.5 x 12mm Go-EZ Screw	18206	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 26mm	21277	FDA UDI	Class II	Active
Cortical Screw 2.8mm x 28mm	20578	FDA UDI	Class II	Active
23mm HBS® Standard Compression	18621	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 32mm	21554	FDA UDI	Class II	Active
12mm X 3 Hbs Std Comp - S. C.	19205	FDA UDI	Class II	Active
BioPro Bipolar Head 60mm	18152	FDA UDI	Class II	Active
26mm X 3.0 Hbs Std Ft	22580	FDA UDI	Class II	Active
1/3 Locking Tubular Plate 12 Hole, Sterile	21196	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 3mm, left Sterile	20950	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 51	13012	FDA UDI	Class II	Active
Kwire Sterile Double Trochar .035	19283	FDA UDI	Class II	Active
Insert Total Mod 14x78	15041	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.