Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
This recall has been terminated (originally issued December 22, 2016).
- Company
- Flower Orthopedics Corporation
- Recall Initiated
- December 22, 2016
- Terminated
- November 27, 2017
- Recall Number
- Z-1113-2017
- Firm Location
- Horsham, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The product is being recalled due to incidence and reports of the product breaking during surgery.
Distribution
Distributed throughout the United States
Lot / Code Info
Device Listing: D267957
Root Cause
Device Design
Action Taken
Flower Orthopedics mailed a letter to customers on December 22, 2016 making them aware of the issue. Customers were asked to return the affected product and to report if any adverse effects resulted from its use.
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