BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x120 due to a manufacturing flaw in the sterile barrier system.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a sterile barrier flaw in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
BioPro, Inc. is recalling 2 units of the Go-EZ Screw 6.5x120 (Item Number 19672) because of a manufacturing flaw in the sterile barrier system. The product is an accessory to the BioPro Go-Ez screw system and the BioPro HBS System, intended for various orthopedic surgical procedures but not for use in the spine.
The affected units are identified by UDI M209196720, Lot Number 123119, and a manufacturing date of 4/29/2019. The recall covers worldwide distribution, including US nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador and Scotland.
Healthcare providers and consumers should stop using the affected product and contact BioPro, Inc. for further instructions or a return.
The recalled product
- 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
- Manufacturer
- BioPro, Inc.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI - M209196720 Lot Number - 123119 MFG Date - 4/29/2019
Distribution
Part of a larger recall action
This product is one of 21 recalled by BioPro, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
Same manufacturer · BioPro, Inc.
See all →- HighUni-polar endo heads recalled over packaging that may compromise sterility
FDA (Devices) · 2025-10-22
- HighMetal and ceramic femoral heads recalled over sterile barrier packaging defect
FDA (Devices) · 2025-10-22
- HighCeramic femoral heads recalled over packaging that may compromise sterile barrier
FDA (Devices) · 2025-10-22
- HighFemoral head implants recalled over packaging that may compromise sterile barrier
FDA (Devices) · 2025-10-22
- HighCeramic endo modular heads recalled over sterile barrier packaging defect
FDA (Devices) · 2025-10-22
Same hazard · sterile barrier failure
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
FDA (Devices) · 2026-05-20
- ModerateB Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall
FDA (Devices) · 2025-05-14
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
- HighMedtronic Clearview Blower Mister Model 22120 recalled for potential unsealed sterile packing
FDA (Devices) · 2024-05-22
- HighExactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging
FDA (Devices) · 2024-04-10