Port Huron, MI, United States
BioPro, Inc. recalls
3 recalls recorded since 2018, most recently on 9 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 September 2025
- Reason
- 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.
- Distribution
- US Domestic distribution to Texas and Michigan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0150-2026, Z-0148-2026, Z-0152-2026, Z-0153-2026, Z-0149-2026, Z-0151-2026
- BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM
- BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 1900
- BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH
- BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
- BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 1
- BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 H
Terminated Class II Medical devices
- Recall started
- 1 February 2022
- Terminated
- 28 February 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0688-2022, Z-0683-2022, Z-0685-2022, Z-0690-2022, Z-0682-2022, Z-0689-2022, Z-0686-2022, Z-0684-2022, Z-0691-2022, Z-0687-2022
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
- Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
- Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 25 June 2019
- Terminated
- 7 May 2020
- Reason
- Manufacturing flaw in the sterile barrier system
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2257-2019, Z-2245-2019, Z-2250-2019, Z-2249-2019, Z-2258-2019, Z-2243-2019, Z-2241-2019, Z-2239-2019, Z-2246-2019, Z-2247-2019, Z-2242-2019, Z-2248-2019 and 9 more
- Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the
- K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended
- Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the
- Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the
- Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the
- K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended
- K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended
- K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the
- and 13 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.