Recall Z-2257-2019— BioPro, Inc.
Class II · Terminated
Class II FDA medical device recall by BioPro, Inc., initiated 2019-06-25, terminated 2020-05-07. It names one FDA 510(k) clearance: K081149. Product: Go-EZ Screw 6.5x120, Item Number 19672 - 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: Manufacturing flaw in the sterile barrier system.
- Recalling firm
- BioPro, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-06-25
- Terminated
- 2020-05-07
- Firm location
- Port Huron, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Go-EZ Screw 6.5x120, Item Number 19672 - 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.