Z-1174-2014Class II

Synthes Small Notch Titanium Reconstructive Plate

Name: Z-1174-2014 Synthes Small Notch Titanium Reconstructive Plate
Creator: Synthes, Inc.
Published: 2014-01-27
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-01-27 / Terminated / root cause: labeling and UDI

FDA source

Synthes, Inc. began a recall of Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate... on 2014-01-27. FDA classified it as Class II and gives the reason as "Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1174-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-27
Posted: 2014-03-11
Terminated: 2016-08-26
Recalling firm: Synthes GmbH
Product: Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Synthes sent an Urgent Medical Medical Device Recall letter, dated January 27, 2013, to Users and Sales Consultants. The letter identified the affected product, reason for recall, potential hazard, and actions to be taken. Customers were instructed to complete the verification section. For questions call 610-719-5450 or contact your Synthes Sales Consultant. .
Quantity in commerce: 18747
Distribution: USA Nationwide Distribution
Product codes and lots: All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, 489.424, and 489.425.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1174-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1174-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10

Product code HRS

K915818Class IISynthes(r) Titanium Small Reconstruction PlateSynthes (Usa) / cleared 1992-01-17

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)