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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 43 of 61

Device	Model / Reference	Registries	Class	Status
Goez Screw 3.5 X 26mm	18213	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 45mm	20865	FDA UDI	Class II	Active
Goez Screw Instrument Tray	20044	FDA UDI	Class I	Active
Medial 4 Column Plate, long, right Sterile	21050	FDA UDI	Class II	Active
Tara Femoral Component 51	10091	FDA UDI	Class II	Active
Head Femoral 32 Md Lt	14095	FDA UDI	Class II	Active
Insert Uni Sm 11.5	10305	FDA UDI	Class II	Active
Insert Cc 26 X 55	11799	FDA UDI	Class II	Active
28mm x 2.5 HBS High Comp	19390	FDA UDI	Class II	Active
Large Staple Clamp	17652	FDA UDI	Class I	Active
Stem Pc Lg 1	10120	FDA UDI	Class II	Active
Goez Screw 2.0 X 32mm	19268	FDA UDI	Class II	Active
19mm x 3 HBS High Comp - S. C.	19192	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 90mm, Sterile	21266	FDA UDI	Class II	Active
Cortical Locking Screw, Mva, 3.5mm X 20mm	20820	FDA UDI	Class II	Active
Drill bit AO QC 2.8 x 110/85mm, Sterile	OL28DBS	FDA UDI	Class I	Active
Compression Sleeve, Left	21649	FDA UDI	Class I	Active
Hbs Screw 2.5 X 34mm Sdst	20512	FDA UDI	Class II	Active
HEAD FEMORAL 28mm +12	19009	FDA UDI	Class II	Active
2.0 x 8mm Go-EZ Screw	18163	FDA UDI	Class II	Active
3.0 x 13mm HBS Screw	19569	FDA UDI	Class II	Active
L-Shaped Fracture Plate 4 holes, right	20873	FDA UDI	Class II	Active
TOE JOINT NPC 10.25mm	16820	FDA UDI	Class II	Active
3.0 x 11mm HBS Screw	19567	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 20mm Sterile	21025	FDA UDI	Class II	Active
2.5 x 20mm Go-EZ Screw	18179	FDA UDI	Class II	Active
Goez Screw 2.0 X 30mm	19267	FDA UDI	Class II	Active
Cortical Screw, Low Head 3.5mm x 12mm, Sterile	21295	FDA UDI	Class II	Active
Cortical Bone Screw 4.5/20mm	16593	FDA UDI	Class II	Active
Burr Fine 14MM	19760	FDA UDI	Class I	Active
Anterior Lateral Tibia Plate 12 Hole, left	21157	FDA UDI	Class II	Active
Ruler for the MTP Fusion Reamer 18/21/24	20967	FDA UDI	Class I	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 9.5 MM	22388	FDA UDI	Class I	Active
Thumb Tmc Pc Lg 19	15098	FDA UDI	Class II	Active
Insert Uni Comp Xlg 10.0	14144	FDA UDI	Class II	Active
Straight Entry Awl	21669	FDA UDI	Class I	Active
Goez 2.0 4.5 Complete Kit	19485	FDA UDI	Class I	Active
Rectangular Plate L	20887	FDA UDI	Class II	Active
4.2mm Drill Bit	21389	FDA UDI	Class I	Active
LARGE STAPLE 30x30	17624	FDA UDI	Class II	Active
Medial Column Plate Module	22933	FDA UDI	Class II	Active
17mm x 2.5 HBS High Comp	19379	FDA UDI	Class II	Active
2.5 x 19mm HBS Screw	19554	FDA UDI	Class II	Active
14mm x 3 HBS High Comp - S. C.	19187	FDA UDI	Class II	Active
Drill Guide 7 - 9MM	17648	FDA UDI	Class I	Active
Fibula Plate 10 Hole, right	21099	FDA UDI	Class II	Active
Uni Ll/Rm Xxlg	10299	FDA UDI	Class II	Active
HEMI EDGE™ TOE LARGE 42mm	19542	FDA UDI	Class II	Active
18mm x 2.5 HBS High Comp	19380	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.0mm x 8mm Sterile	20580	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.