Z-2058-2013Class II

Synthes Trauma Nail System. The devices are indication for bone fixation

Name: Z-2058-2013 Synthes Trauma Nail System. The devices are indication for bone fixation
Creator: Synthes USA HQ, Inc.
Published: 2012-11-02
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2012-11-02 / Terminated / root cause: packaging

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Trauma Nail System. The devices are indication for bone fixation on 2012-11-02. FDA classified it as Class II and gives the reason as "Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2058-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-02
Posted: 2013-08-26
Terminated: 2016-09-27
Recalling firm: Synthes GmbH
Product: Synthes Trauma Nail System. The devices are indication for bone fixation.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm initiated their recall of this product on November 2, 2012 by sending an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter to all consignees. The letter explained the problem and gave instructions for consignees to examine their inventory and urged consignees to return the identified devices. The letter stated If returning the product would adversely impact their ability to provide necessary medical care to patients, they should re-sterilize the product per Pre-Vacuum Sterilization instructions contained in the Instruction for Use.
Quantity in commerce: 1,011,783
Distribution: Nationwide distribution.
Product codes and lots: Trauma Ex Nails, all lot numbers up to and including lot # 7072305 and Trochanteric Fixation Nails, all lot numbers up to and including lot # 7060897

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-26

Product code HSB

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)