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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 40 of 61

Device	Model / Reference	Registries	Class	Status
Drill Staple Small (1.8mm)	17660	FDA UDI	Class I	Active
Goez Screw 3.0 X 16mm	18190	FDA UDI	Class II	Active
Insert Providence 28x50	15127	FDA UDI	Class II	Active
38mm X 2.5 Hbs Std Comp-S.c.	19344	FDA UDI	Class II	Active
3.0 x 27mm HBS Screw	19583	FDA UDI	Class II	Active
23mm x 2.5 HBS High Comp	19385	FDA UDI	Class II	Active
Toe Joint Cobalt Chrome Npc M/L 21.5mm	14958	FDA UDI	Class II	Active
Insert Total 24x86	10294	FDA UDI	Class II	Active
Cortical Screw 2.5mm x 8mm	20549	FDA UDI	Class II	Active
Horizon Subtalar Gen 212mm	22648	FDA UDI	Class II	Active
Osteotomy Plate Module	22934	FDA UDI	Class II	Active
Endo Modular Ceramic Md 38	13013	FDA UDI	Class II	Active
Goez Screw 3.0 X 12mm	18188	FDA UDI	Class II	Active
3.0 x 18mm HBS Screw	19574	FDA UDI	Class II	Active
6.5 x 38mm Go-EZ Screw	19655	FDA UDI	Class II	Active
Drill Guide Adjustable	17651	FDA UDI	Class I	Active
Staple Positioner 18x16	19514	FDA UDI	Class I	Active
Stem Pc Sh 2	10131	FDA UDI	Class II	Active
20mm HBS® High Compression	18639	FDA UDI	Class II	Active
11mm Nail Cap + 5mm	21638	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 36mm	21557	FDA UDI	Class II	Active
4.5 x 24mm Go-EZ Screw	18248	FDA UDI	Class II	Active
40mm X 2.5 Hbs Std Comp-S.c.	19345	FDA UDI	Class II	Active
Drill Guide 4 Leg 18x16	18292	FDA UDI	Class I	Active
Goez Screw 4.0 X 12mm	18229	FDA UDI	Class II	Active
Horizon Subtalar Gen 2 - 11mm Implant	22647	FDA UDI	Class II	Active
Hbs Screw 3.0 X 34mm Sdst	20528	FDA UDI	Class II	Active
Goez Screw 4.0 X 20mm	18233	FDA UDI	Class II	Active
Drill Guide 4 Leg 10x8	18290	FDA UDI	Class I	Active
Mod Thumb Oscillating Burr Fine 13mm	17371	FDA UDI	Class I	Active
10mm x 2.5 HBS High Comp	19372	FDA UDI	Class II	Active
Dorsal TMT I Fusion Plate 1mm, left Sterile	20948	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 55mm	20867	FDA UDI	Class II	Active
21mm HBS® High Compression	18640	FDA UDI	Class II	Active
Depth Gauge 2.0/2.5/2.8mm – 40mm	20635	FDA UDI	Class I	Active
MVA Cortical Locking screw 2.0mm x 12mm	20473	FDA UDI	Class II	Active
Osteotome, Curved, 15mm	95-1515C	FDA UDI	Class I	Active
Burr Guide 3 Leg 14x12	18310	FDA UDI	Class I	Active
K-Wire Sterile Single Trochar .035	19106	FDA UDI	Class II	Active
3.0 x 23mm HBS Screw	19579	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.5mm x 16mm Sterile	20598	FDA UDI	Class II	Active
MTP Fusion Revision Plate Left	20612	FDA UDI	Class II	Active
Insert Total 8x66	10254	FDA UDI	Class II	Active
40mm X 3.0 Hbs Screw Sdst Pkg	20531	FDA UDI	Class II	Active
Cloverleaf Plate 4 holes	20875	FDA UDI	Class II	Active
Accu-Cut™ Standard	19505	FDA UDI	Class I	Active
Cotton Plate 6mm Sterile	20963	FDA UDI	Class II	Active
Stem Pc Lg 7	10126	FDA UDI	Class II	Active
Goez Screw 4.5 X 36mm	19033	FDA UDI	Class II	Active
3.0 x 30mm HBS Screw	19586	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.