Go-EZ Screw 6.5x32, Item Number 19652 - 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-2254-2019
Product Description
Go-EZ Screw 6.5x32, Item Number 19652 - 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
- 3 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? ▼
Go-EZ Screw 6.5x32, Item Number 19652 - 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: 3 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-2254-2019.
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