Agency classClass IIOur severity:High FDA (Devices)·Z-2254-2019·Announced 2019-08-21

BioPro Go-EZ Screw Recalled for Sterile Barrier Manufacturing Flaw

BioPro, Inc. is recalling 3 units of Go-EZ Screw 6.5x32 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 (infection) even though no specific injuries are reported in the source text.

Plain-English summary

BioPro, Inc. is recalling 3 units of the Go-EZ Screw 6.5x32 (Item Number 19652) 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 M209196520, Lot Number 123106, and a manufacturing date of 4/26/2019. The recall covers worldwide distribution, including US nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and the countries of Ecuador and Scotland.

Healthcare providers and consumers should stop using the affected product and contact BioPro, Inc. for further instructions.

The recalled product

Product: Go-EZ Screw 6.5x32, Item Number 19652 - 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.
Category: Medical Device — Orthopedic Surgical Instrument
Hazard: sterile-barrier-defect
infection-risk
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 - M209196520 Lot Number - 123106 MFG Date - 4/26/2019

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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 →

Same manufacturer · BioPro, Inc.

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