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Drill Template and the Saw Guide for the Ulna Osteotomy… recallZ-1274-2014 · Synthes, Inc. · initiated Jan 7, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.

Recall details

Recall number
Z-1274-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 7, 2014
Posted by the FDA
Mar 25, 2014
Recalling firm
Synthes, Inc.
Quantity
343
Product code
HRS
FDA submissions
K113364
Distribution
Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.

Product 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.

Code information (models, lots, serial numbers)

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.

Other devices under the same FDA submission

30 devices cleared under K113364 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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