BioPro, Inc.: 37 FDA recall reports
Every medical device recall the FDA has published for BioPro, Inc.. The fault, and how the agency graded it.
37Reports
0Class I
6Ongoing
2025-10-22Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR
Z-0150-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM
- Where it went
- US Domestic distribution to Texas and Michigan.
- How much
- 147 total
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 1859
Z-0148-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9
- Where it went
- US Domestic distribution to Texas and Michigan.
- How much
- 147 total
BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CER
Z-0152-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36
- Where it went
- US Domestic distribution to Texas and Michigan.
- How much
- 147 total
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 1409
Z-0153-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- US Domestic distribution to Texas and Michigan.
- How much
- 147 total
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41
Z-0149-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55
- Where it went
- US Domestic distribution to Texas and Michigan.
- How much
- 147 total
BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024
Z-0151-2026 · Class II · reported 2025-10-22 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 HEAD FEMORAL CERAMIC 32MM +3
- Where it went
- US Domestic distribution to Texas and Michigan.
- How much
- 147 total
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
Z-0688-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
Z-0683-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
Z-0685-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
Z-0690-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
Z-0682-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
Z-0689-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
Z-0686-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
Z-0684-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
Z-0691-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
Z-0687-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- 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.
- Product
- Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036
- Where it went
- US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.
Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the BioPro Go-Ez screw system and the B
Z-2257-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 2 units
K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw sy
Z-2245-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 for use in the spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 240 units
Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2250-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 3 units
Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2249-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 4 units
Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2258-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 3 units
K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw sy
Z-2243-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 for use in the spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 350 units
K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw s
Z-2241-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 for use in the spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 1 unit
K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2239-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- 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 spine.
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 17 units
Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2246-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- Go-EZ Screw 6.5x30, Item Number 19651 - 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 3 units
Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the B
Z-2247-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- Go-EZ Screw 6.5x100, Item Number 19668 - 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 4 units
K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accessories to the BioPro Go-Ez screw sy
Z-2242-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 350 units
Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2248-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- Go-EZ Screw 6.5x36, Item Number 19654 - 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 3 units
Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the Bi
Z-2254-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- Go-EZ Screw 6.5x32, Item Number 19652 - 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 3 units
Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the BioPro Go-Ez screw system and the B
Z-2255-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Manufacturing flaw in the sterile barrier system
- Product
- Go-EZ Screw 6.5x105, Item Number 19669 - 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 spine
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- How much
- 2 units
Showing the 30 most recent of 37. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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