Recall Z-1113-2017 ยท LXH Orthopedic Manual Surgical Instrument
Flower Orthopedics Corporation
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
| Date | Dec 22, 2016 |
| Status | Terminated |
| Reason | The product is being recalled due to incidence and reports of the product breaking during surgery. |
| Root cause | Device Design |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.