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.
This recall has been terminated (originally issued March 25, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- January 7, 2014
- Posted
- March 25, 2014
- Terminated
- September 10, 2015
- Recall Number
- Z-1274-2014
- Quantity
- 343
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
Lot / Code Info
Part Nos. 03.111.900 through 03.111.905, with Lot Nos. 779372, 2638601, 7769386, 2638603, 7836420, 7772531, 2638604, 7836422, 7772538, 2638605, 7836423, 7915554, 7772543, 7772542, 7872775, 8400287, 7772554, 7772555, and 8229040.
Root Cause
Component design/selection
Action Taken
A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.