BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw
BioPro, Inc. is recalling 4 units of Go-EZ Screw 6.5x100 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 surgical implant, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
BioPro, Inc. is recalling 4 units of the Go-EZ Screw 6.5x100, Item Number 19668. These medical devices are accessories 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 recall is due to a manufacturing flaw in the sterile barrier system. The affected units have UDI M209196680, Lot Number 123115, and a manufacturing date of 4/26/2019.
The products were distributed worldwide, including in the US states of Florida, Louisiana, Maryland, North Carolina, New York, Oregon, and Texas, as well as in Ecuador and Scotland. Healthcare providers should stop using the affected devices and contact BioPro, Inc. for further instructions.
The recalled product
- 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
- Manufacturer
- BioPro, Inc.
- Affected units
- 4
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 - M209196680 Lot Number - 123115 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.
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