Recall Z-1274-2014 ยท HRS Plate, Fixation, Bone
Synthes, Inc.
Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.
| Date | Mar 25, 2014 (initiated Jan 7, 2014) |
| Status | Terminated |
| Reason | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the Drill Template. |
| Root cause | Component design/selection |
| Action | A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users. |
| Quantity | 343 |
| Distribution | Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113364 | 2.7MM LCP ULNA OSTEOTOMY SYSTEM Synthes (USA) Products, LLC, Feb 29, 2012 |