Recall Z-2240-2016 ยท JDO Device, Fixation, Proximal Femoral, Implant
Biomet, Inc.
TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric
| Date | Jul 19, 2016 (initiated Jun 10, 2016) |
| Status | Terminated |
| Reason | The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur. |
| Root cause | Device Design |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 10, 2016, to all affected customers via courier. Distributors and hospitals were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-6725, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity | 5458 units |
| Distribution | Worldwide Distribution - US (Nationwide) Internationally to Australia, The Netherlands, and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140018 | TSP HIP FRACTURE PLATING SYSTEM Biomet, Inc., Apr 4, 2014 |