BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 350 units of K-Wire Single Trocar 1.6x150mm 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 source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a manufacturing flaw in the sterile barrier system, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
BioPro, Inc. is recalling 350 units of the K-Wire Single Trocar 1.6x150mm, Item Number OL15016S. 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 because of a manufacturing flaw in the sterile barrier system. The affected units are identified by UDI M209OL15016S0, Lot Number 123213, and a manufacturing date of 4/23/2019.
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. No specific instructions for consumers are provided in the source text, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - 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.
- Hazard
- 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 - M209OL15016S0 Lot Number - 123213 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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