BioPro, Inc.
FDA Regulatory Profile
BioPro, Inc. appears in FDA public data with 37 recalls, 41 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0152-2026, Class II) was initiated on September 9, 2025. Its most recent 510(k) clearance was granted on September 14, 2017.
Summary
- Total Recalls
- 37
- 510(k) Clearances
- 41
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0152-2026 | Class II | BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO M | September 9, 2025 |
| Z-0148-2026 | Class II | BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Descript | September 9, 2025 |
| Z-0150-2026 | Class II | BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 181 | September 9, 2025 |
| Z-0149-2026 | Class II | BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 E | September 9, 2025 |
| Z-0153-2026 | Class II | BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 M | September 9, 2025 |
| Z-0151-2026 | Class II | BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM | September 9, 2025 |
| Z-0688-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 | February 1, 2022 |
| Z-0685-2022 | Class II | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 | February 1, 2022 |
| Z-0689-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 | February 1, 2022 |
| Z-0683-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 | February 1, 2022 |
| Z-0686-2022 | Class II | Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 | February 1, 2022 |
| Z-0690-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 | February 1, 2022 |
| Z-0684-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 | February 1, 2022 |
| Z-0687-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 | February 1, 2022 |
| Z-0691-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 | February 1, 2022 |
| Z-0682-2022 | Class II | Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 | February 1, 2022 |
| Z-2253-2019 | Class II | Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system | June 25, 2019 |
| Z-2258-2019 | Class II | Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system | June 25, 2019 |
| Z-2254-2019 | Class II | Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system | June 25, 2019 |
| Z-2252-2019 | Class II | Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system a | June 25, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163627 | Shotel Ankle Arthrodesis Nail System | September 14, 2017 |
| K162674 | BioPro Foot Plating Systems | June 16, 2017 |
| K132510 | BIOPRO - INFINITY PLATE ANCHOR SYSTEM | October 24, 2013 |
| K130298 | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM | June 18, 2013 |
| K121973 | BIOPRO HEMI-EDGE TOE SYSTEM | October 30, 2012 |
| K100761 | BIOPRO POLAR HEAD | December 3, 2010 |
| K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW | June 3, 2010 |
| K090208 | BIOPRO FEMORAL HEADS | May 22, 2009 |
| K083490 | BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685 | March 18, 2009 |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | December 15, 2008 |
| K081149 | BIOPRO GO-EZ SCREW | August 5, 2008 |
| K072298 | BIOPRO MEMORY STAPLE, MODELS 18062-18073 | October 29, 2007 |
| K061798 | BIOPRO MEMORY STAPLE | August 21, 2006 |
| K061089 | MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 | June 20, 2006 |
| K052596 | MODULAR THUMB IMPLANT, MODELS 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,1724 | November 15, 2005 |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | May 18, 2005 |
| K041595 | TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 | November 12, 2004 |
| K041936 | BIOPRO SUBTALAR IMPLANT | September 8, 2004 |
| K011459 | WUJIN #3 FEMORAL BONE PLATE | August 7, 2001 |
| K011460 | WUJIN #3 TIBIAL BONE PLATE | August 7, 2001 |