BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 2.5x170mm 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 and involves a sterile barrier flaw in a medical device, which presents a risk of harm without reported injuries, fitting the 'High' severity criteria.
Plain-English summary
BioPro, Inc. is recalling 350 units of the K-Wire Single Trocar 2.5x170mm (Item Number OL17025S). 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 due to a manufacturing flaw in the sterile barrier system. The affected units are identified by UDI M209OL17025S0, Lot Number 123218, and a manufacturing date of 4/24/2019.
The products were distributed worldwide, including nationwide distribution in the United States in the states of Florida, Louisiana, Maryland, North Carolina, New York, Oregon, and Texas, as well as in Ecuador and Scotland. Users should contact BioPro, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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
- 350
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 - M209OL17025S0 Lot Number - 123218 MFG Date - 4/24/2019
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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