Z-0986-2014Class II

Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral

Name: Z-0986-2014 Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral
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 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral on 2014-01-27. FDA classified it as Class II and gives the reason as "Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label". 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-0986-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-27
Posted: 2014-02-16
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: A recall notification letter, dated January 27, 2013, was sent to End Users and sales consultants.
Quantity in commerce: 1,132,096
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
Product codes and lots: part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0986-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-16

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

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)