Z-2091-2015Class II

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to...

Name: Z-2091-2015 Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to...
Creator: Synthes (USA) Products LLC
Published: 2015-06-10
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-06-10 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent... on 2015-06-10. FDA classified it as Class II and gives the reason as "The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017)". 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-2091-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-10
Posted: 2015-07-16
Terminated: 2016-08-18
Recalling firm: Synthes (USA) Products LLC
Product: Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.
Quantity in commerce: 32
Distribution: Nationwide Distribution.
Product codes and lots: Part Number Lot Numbers 03.037.024 T102759

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2091-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2091-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-16

Product code HSB

K131548Class IISynthes Trochanteric Fixation Nail - Advanced SystemSynthes (USA) Products, LLC / cleared 2014-02-28

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)