BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw
BioPro, Inc. is recalling 2 units of Go-EZ Screw 6.5x85 due to a manufacturing flaw in the sterile barrier system. The devices were distributed in the US and internationally.
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 infection or harm, but the source text does not report any specific illnesses or injuries, aligning with the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
BioPro, Inc. is voluntarily recalling 2 units of the Go-EZ Screw 6.5x85, Item Number 19665. This medical device 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 recall was initiated due to a manufacturing flaw in the sterile barrier system. The affected units are identified by UDI M209196650, Lot Number 123112, and a manufacturing date of 4/26/2019.
The devices 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 and patients should contact BioPro, Inc. for further instructions regarding the return or replacement of these specific units.
The recalled product
- Product
- 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
- 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 - M209196650 Lot Number - 123112 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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