Z-0369-2014Class II

Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail...

Name: Z-0369-2014 Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail...
Creator: Synthes USA HQ, Inc.
Published: 2013-10-03
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-10-03 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and... on 2013-10-03. FDA classified it as Class II and gives the reason as "A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed". 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-0369-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-03
Posted: 2013-11-20
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Synthes sent a Field Safety Notice dated October 3, 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 review the options provided in the Field Safety Notice to clarify and mitigate the potential risk. Customers were asked to prepare a list of the affected part and lot numbers and contact the Complaint Unit at 610-719-5596 to receive a Return Authorization Number. Complete and return the Verification Form with the product and Return Authorization number. Customers were also asked to forward the Field Safety Notice to anyone in their facility that needs to be informed. Customers were asked to maintain a copy of the Field Safety Notice. Customers with questions were asked to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 350195
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.
Product codes and lots: part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 5615864 through 7423581

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0369-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0369-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-20

Product code HSB

K070294Class IISynthes Trochanteric Fixation Nail (Tfn) System, Additional Helical BladesSynthes (Usa) / cleared 2007-03-01

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)