BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x115 due to a manufacturing flaw in the sterile barrier system. The devices are intended for orthopedic surgical procedures.
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 specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
BioPro, Inc. is recalling two units of the Go-EZ Screw 6.5x115 (Item Number 19671) due to a manufacturing flaw in the sterile barrier system. This 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 M209196710, Lot Number 123118, and a manufacturing date of 4/25/2019. 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 devices and contact BioPro, Inc. for further instructions regarding the recall.
The recalled product
- Product
- 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
- 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 - M209196710 Lot Number - 123118 MFG Date - 4/25/2019
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 defect
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21
- HighB Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
FDA (Devices) · 2025-05-14
- HighSocrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
FDA (Devices) · 2025-03-05