Z-0452-2014Class II

Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the...

Name: Z-0452-2014 Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the...
Creator: Synthes USA HQ, Inc.
Published: 2013-07-30
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-30 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur on 2013-07-30. FDA classified it as Class II and gives the reason as "Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0452-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-12-05
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affeccted product to obtain a Return Authorization Number, Complete the Verification Section of the letter by checking the appropriate box indicating the affected product has been located. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132. Customers should complete and return the Verification Frorm even if they do not have any of the affected product and return by fax to 1-888-386-2077 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Trauma Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 17
Distribution: Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
Product codes and lots: Part # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0452-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0452-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-11	2013-12-04

Product code HSB

K011857Class IISynthes (USA) Trochanteric Fixation Nail (Tfn) SystemSynthes (Usa) / cleared 2001-09-12

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)