Recall Z-1174-2014 ยท HRS Plate, Fixation, Bone
Synthes, Inc.
Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of ho
| Date | Mar 11, 2014 (initiated Jan 27, 2014) |
| Status | Terminated |
| Reason | Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. |
| Root cause | Labeling design |
| Action | Synthes sent an Urgent Medical Medical Device Recall letter, dated January 27, 2013, to Users and Sales Consultants. The letter identified the affected product, reason for recall, potential hazard, and actions to be taken. Customers were instructed to complete the verification section. For questions call 610-719-5450 or contact your Synthes Sales Consultant. . |
| Quantity | 18747 |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K915818 | SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE Synthes (Usa), Jan 17, 1992 |