Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.

FDA Recall #Z-1113-2017 — Class II — December 22, 2016

Recall #Z-1113-2017 Date: December 22, 2016 Classification: Class II Status: Terminated

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.

Recalling Firm

Flower Orthopedics Corporation — Horsham, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

N/A

Distribution

Distributed throughout the United States

Code Information

Device Listing: D267957

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated