Z-0219-2015Class II

10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable...

Name: Z-0219-2015 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable...
Creator: Synthes, Inc.
Published: 2014-10-29
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-10-29 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur on 2014-10-29. FDA classified it as Class II and gives the reason as "The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise...". 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-0219-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-29
Posted: 2014-11-14
Terminated: 2015-12-18
Recalling firm: Synthes GmbH
Product: 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: An urgent medical device recall notice, dated October 29, 2014, was sent to end users that identified the product, problem and action to be taken. Customers were instructed to return the device to Synthes along with completing the verification section of the notice.
Quantity in commerce: 6
Distribution: US Distribution in the states of: AK, FL, OH, OK, and TX.
Product codes and lots: part number: 456.316S, lot number: 7782247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0219-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0219-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-26	2014-11-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)