Z-0474-2014Class II

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN...

Name: Z-0474-2014 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN...
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 Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable... on 2013-07-30. FDA classified it as Class II and gives the reason as "Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging". 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-0474-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-12-10
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were instructed to take the following steps: Complete the attached Verification Section at the end of the letter by checking the appropriate box indicating no affected product has been located. Return the documents to Synthes by fax to 610-251-9005 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 12
Distribution: Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Product codes and lots: Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0474-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0474-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-10

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)