BioPro K-Wire Single Trocar Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 240 units of K-Wire Single Trocar 2.5x150mm 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, which poses a risk of harm (infection) but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
BioPro, Inc. is recalling 240 units of the K-Wire Single Trocar 2.5x150mm (Item Number OL15025S). 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 M209OL15025S0, Lot Number 123219, and a manufacturing date of 4/24/2019. The products were distributed worldwide, including in the US states of Florida, Louisiana, Maryland, North Carolina, New York, Oregon, and Texas, as well as in Ecuador and Scotland.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected products and contact BioPro, Inc. for further instructions.
The recalled product
- Product
- K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - 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
- 240
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 - M209OL15025S0 Lot Number - 123219 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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