BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.1x150mm 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 poses a risk of harm (infection) even though no injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
BioPro, Inc. is recalling 350 units of the K-Wire Single Trocar 1.1x150mm (Item Number OL15011S). The recall is due to 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 have UDI M209OL15011S0, Lot Number 123220, and a manufacturing date of 4/23/2019. 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.
The FDA has classified this as a Class II recall. The source text does not report any illnesses or injuries associated with this defect. Healthcare providers and patients should stop using the affected units and contact BioPro, Inc. for further instructions.
The recalled product
- Product
- K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - 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 - M209OL15011S0 Lot Number - 123220 MFG Date - 4/23/2019
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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