Z-1352-2015Class II

Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm...

Name: Z-1352-2015 Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm...
Creator: Synthes, Inc.
Published: 2015-02-24
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2015-02-24 / Terminated / root cause: design

FDA source

Synthes, Inc. began a recall of Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The... on 2015-02-24. FDA classified it as Class II and gives the reason as "The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1352-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-24
Posted: 2015-03-30
Terminated: 2015-09-21
Recalling firm: Synthes GmbH
Product: Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Root cause tag: design
FDA root cause: Component design/selection
Action: DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.
Quantity in commerce: 131
Distribution: US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Product codes and lots: Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1352-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1352-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-30

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