Recall Z-2245-2019— BioPro, Inc.
Class II · Terminated
Class II FDA medical device recall by BioPro, Inc., initiated 2019-06-25, terminated 2020-05-07. FDA's recall record names no specific 510(k) clearance for this event. 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. 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
Product description
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
Reason for recall
Manufacturing flaw in the sterile barrier system
Data sourced from openFDA. This site is unofficial and independent of the FDA.