FDA Recall
Terminated
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Recall: Z-1113-2017
·
Initiated December 22, 2016
Recall
- Recall Number
- Z-1113-2017
- Event Number
- 76156
- Firm
- Flower Orthopedics Corporation
- FEI Number
- 3009996260
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- December 22, 2016
- Terminated
- November 27, 2017
- Address
- 100 Witmer Rd, Ste 280, Horsham, PA, 19044-2647
Description
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.
Action
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.
Distribution
Distributed throughout the United States