BioPro Go-EZ Screw Recalled Due to Sterile Barrier Flaw
BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x30 due to a manufacturing flaw in the sterile barrier system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 and involves a sterile barrier flaw in a medical device, which poses a risk of harm without reported injuries, fitting the High severity criteria.
Plain-English summary
BioPro, Inc. is recalling 3 units of the Go-EZ Screw 6.5x30, Item Number 19651. The recall is due to 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 have UDI M209196510, Lot Number 123105, and a manufacturing date of 4/26/2019. The products were distributed worldwide, including in the US states of FL, LA, MD, NC, NY, OR, and TX, as well as in Ecuador and Scotland.
Healthcare providers and consumers should stop using the affected products and contact BioPro, Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- BioPro, Inc.
- Hazard
- Affected units
- 3
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 - M209196510 Lot Number - 123105 MFG Date - 4/26/2019
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 →- HighBlood Culture Kits Recalled Due to Potential Sterile Barrier Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
- 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
Similar recalls
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighGynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2025-01-22
- HighECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
FDA (Devices) · 2025-01-22
- HighBiomet Cannulated Screw System Recalled for Potential Sterile Seal Breach
FDA (Devices) · 2020-12-23
- HighOrthoPediatrics Recalls Response Spine Pedicle Screws Due to Manufacturing Defect
FDA (Devices) · 2016-01-20
- HighSurgical Retractor Kits Recalled for Potential Sterile Barrier Breach
FDA (Devices) · 2025-01-22