Z-1113-2017 Class II Terminated
FDA device recall Z-1113-2017 was initiated by Flower Orthopedics Corporation on December 22, 2016 and is designated Class II. Reason for recall: The product is being recalled due to incidence and reports of the product breaking during surgery. The recall status is terminated (terminated November 27, 2017). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- February 8, 2017
- Initiation Date
- December 22, 2016
- Termination Date
- November 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
Distributed throughout the United States
Code Information
Device Listing: D267957