BioPro K-Wire Sterile Single Trochar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling K-Wire Sterile Single Trochar units 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 medical device, which poses a risk of harm (infection) but the source does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioPro, Inc. is recalling the K-Wire Sterile Single Trochar .045, Item Number 19108. 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 is being conducted due to a manufacturing flaw in the sterile barrier system. The affected units are identified by UDI M209191080, Lot Number 123131, and a manufacturing date of 4/2/2019.
Distribution was worldwide, including US nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and in the countries of Ecuador and Scotland. Users should stop using the affected devices and contact BioPro, Inc. for further instructions.
The recalled product
- Product
- K-Wire Sterile Single Trochar .045, Item Number 19108 - 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
- 1
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 - M209191080 Lot Number - 123131 MFG Date - 4/2/2019
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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