BioPro Go-EZ Screw 6.5x120 Recall: Sterile Barrier Manufacturing Flaw
BioPro recalls Go-EZ Screw 6.5x120 (Item 19672) due to a manufacturing flaw in the sterile barrier system. This affects orthopedic surgical accessories used with the BioPro HBS system.
Recall notice
Manufacturing flaw in the sterile barrier system
Contact the company
What happened, in plain English
BioPro is recalling Go-EZ Screw 6.5x120 (Item 19672) because of a manufacturing flaw in the sterile barrier system. This could lead to contamination during surgical procedures if the screw is used without proper sterilization. Read more at govinfonow.com/recall/67582-biopro-go-ez-screw-6-5x120-recall-sterile-barrier-manufacturing.
Source Summary by GovInfoNow · govinfonow.com/recall/67582-biopro-go-ez-screw-6-5x120-recall-sterile-barrier-manufacturing · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2257-2019
Cite this page
“BioPro Go-EZ Screw 6.5x120 Recall: Sterile Barrier Manufacturing Flaw.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67582-biopro-go-ez-screw-6-5x120-recall-sterile-barrier-manufacturing. Based on FDA recall #Z-2257-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2257-2019%22&limit=1).
Why it’s dangerous
The sterile barrier system has a manufacturing flaw that could compromise its ability to maintain sterility during surgical procedures. This might lead to infections or contamination if the screw is used without proper sterilization.
Who’s affected
Orthopedic surgeons and medical facilities using the Go-EZ Screw 6.5x120 (Item 19672) for surgical procedures. Patients undergoing orthopedic surgery with this screw are at risk of contamination.
How to tell if you have this one
Look for the Go-EZ Screw 6.5x120 with Item Number 19672. The product was sold with Lot Number 123119 and manufactured on April 29, 2019.
- Brand
BioPro- Category
Medical device
All 21 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2239-2019 | 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.; UDI M209196880 Lot Number - 122572 MFD Date - 4/23/2019 | 17 units |
| Z-2240-2019 | K-Wire Sterile Single Trochar, Item Number 19106 - 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; UDI - M209191060 Lot Number - 123130 MFG Date - 4/29/2019 | 6 units |
| Z-2241-2019 | 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; UDI - M209191080 Lot Number - 123131 MFG Date - 4/2/2019 | 1 unit |
| Z-2242-2019 | 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; UDI - M209OL17025S0 Lot Number - 123218 MFG Date - 4/24/2019 | 350 units |
| Z-2243-2019 | 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; UDI - M209OL15016S0 Lot Number - 123213 MFG Date - 4/23/2019 | 350 units |
| Z-2244-2019 | K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - 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; UDI - M209OL15011S0 Lot Number - 123220 MFG Date - 4/23/2019 | 350 units |
| Z-2245-2019 | 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; UDI - M209OL15025S0 Lot Number - 123219 MFG Date - 4/24/2019 | 240 units |
| Z-2246-2019 | 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; UDI - M209196510 Lot Number - 123105 MFG Date - 4/26/2019 | 3 units |
| Z-2247-2019 | 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; UDI - M209196680 Lot Number - 123115 MFG Date - 4/26/2019 | 4 units |
| Z-2248-2019 | 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; UDI - M209196540 Lot Number - 123108 MFG Date - 4/26/2019 | 3 units |
| Z-2249-2019 | 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; UDI - M209196670 Lot Number - 123114 MFG Date - 4/25/2019 | 4 units |
| Z-2250-2019 | 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; UDI - M209196530 Lot Number - 123107 MFG Date - 4/26/2019 | 3 units |
| Z-2251-2019 | Go-EZ Screw 6.5x85, Item Number 19665 - 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; UDI - M209196650 Lot Number - 123112 MFG Date - 4/26/2019 | 2 units |
| Z-2252-2019 | Go-EZ Screw 6.5x90, Item Number 19666 - 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; UDI - M209196660 Lot Number - 123113 MFG Date - 4/29/2019 | 4 units |
| Z-2253-2019 | Go-EZ Screw 6.5x115, Item Number 19671 - 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; UDI - M209196710 Lot Number - 123118 MFG Date - 4/25/2019 | 2 units |
| Z-2254-2019 | 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; UDI - M209196520 Lot Number - 123106 MFG Date - 4/26/2019 | 3 units |
| Z-2255-2019 | 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; UDI - M209196690 Lot Number - 123116 MFG Date - 4/26/2019 | 2 units |
| Z-2256-2019 | Go-EZ Screw 6.5x110, Item Number 19670 - 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; UDI - M209196700 Lot Number - 123117 MFG Date - 4/26/2019 | 2 units |
| Z-2257-2019 | 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; UDI - M209196720 Lot Number - 123119 MFG Date - 4/29/2019 | 2 units |
| Z-2258-2019 | 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; UDI - M209196550 Lot Number - 123109 MFG Date - 4/26/2019 | 3 units |
| Z-2259-2019 | K-Wire HBS Sterile Lot, 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; UDI - M209196880 Lot Number - 123305 MFG Date - 4/11/2019 | 17 units |
What to do — step by step
Check Product Details
Verify the Item Number 19672, Lot Number 123119, and Manufacturing Date of April 29, 2019.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Louisiana, Maryland, New York, North Carolina, Oregon, Texas.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product intended for spinal surgery?
No, the product is intended for various orthopedic surgical procedures but not for spinal surgery.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2257-2019 (June 25, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2257-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.