Z-1274-2014Class II

Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures...

Name: Z-1274-2014 Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures...
Creator: Synthes, Inc.
Published: 2014-01-07
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-01-07 / Terminated / root cause: design

FDA source

Synthes, Inc. began a recall of Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small... on 2014-01-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1274-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-07
Posted: 2014-03-25
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: 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 code: HRS Plate, Fixation, Bone
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: A recall notification letter, dated January 7, 2013, was sent to sales consultants and Users.
Quantity in commerce: 343
Distribution: Nationwide Distribution-including the states of AR, AK, VA, IN, PA, OH, CT, TX, MI, WI, NC, CO, IL, and MA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1274-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1274-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25

Product code HRS

K113364Class II2.7Mm Lcp Ulna Osteotomy SystemSynthes (USA) Products, LLC / cleared 2012-02-29

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)