BioPro K-Wire HBS Sterile Lots Recalled for Sterile Barrier Flaw
BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile Lots due to a manufacturing flaw in the sterile barrier system.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the source text does not report any illnesses or injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
BioPro, Inc. is recalling 17 units of K-Wire HBS Sterile Lots, Item Number 19688. These medical devices are accessories 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 M209196880, Lot Number 123305, and a manufacturing date of 4/11/2019.
The affected 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. Consumers and healthcare providers should stop using the affected units and contact BioPro, Inc. for further instructions.
The recalled product
- Product
- K-Wire HBS Sterile Lot, Item Number 19688 - 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
- 17
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 - M209196880 Lot Number - 123305 MFG Date - 4/11/2019
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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