FDA Recall
Terminated
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.
Recall: Z-1274-2014
·
Initiated January 7, 2014
Recall
- Recall Number
- Z-1274-2014
- Event Number
- 67263
- Firm
- Synthes, Inc.
- FEI Number
- 3005180112
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- January 7, 2014
- Posted
- March 25, 2014
- Terminated
- September 10, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
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.
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.
Action
A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
Distribution
Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
Quantity
343