Recall Z-1113-2017— Flower Orthopedics Corporation
Class II · Terminated
Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2016-12-22, terminated 2017-11-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.. Reason: The product is being recalled due to incidence and reports of the product breaking during surgery..
- Recalling firm
- Flower Orthopedics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-22
- Terminated
- 2017-11-27
- Firm location
- Horsham, PA, United States
Product description
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Reason for recall
The product is being recalled due to incidence and reports of the product breaking during surgery.
Data sourced from openFDA. This site is unofficial and independent of the FDA.