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.
FDA Recall Z-1274-2014 · Posted 2014-03-25
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Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2014-01-07
Date Terminated2015-09-10
Product Quantity343
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.
Firm Action
A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
Root Cause
Component design/selection
Distribution Pattern
Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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