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
Reported: August 21, 2019 Initiated: June 25, 2019 #Z-2242-2019
Product Description
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
Reason for Recall
Manufacturing flaw in the sterile barrier system
Details
- Recalling Firm
- BioPro, Inc.
- Units Affected
- 350 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
- Location
- Port Huron, MI
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by BioPro, Inc.. Units affected: 350 units.
Why was this product recalled? ▼
Manufacturing flaw in the sterile barrier system
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2019. Severity: Moderate. Recall number: Z-2242-2019.
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