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.
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. 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.
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