Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1274-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: January 7, 2014

Date Posted: April 2, 2014

Recall Number: Z-1274-2014

Event ID: 67263

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.

Status: Terminated

Product Quantity: 343

Code Information:

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.

Distribution Pattern:

Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.

Voluntary or Mandated:

Voluntary: Firm initiated