Z-0407-2014Class II

Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral...

Name: Z-0407-2014 Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral...
Creator: Synthes USA HQ, Inc.
Published: 2013-07-30
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-30 / Terminated / root cause: packaging

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures on 2013-07-30. FDA classified it as Class II and gives the reason as "The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail". 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-0407-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-30
Posted: 2013-11-27
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Product code: JDS Nail, Fixation, Bone
Reason for recall: The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.
Root cause tag: packaging
FDA root cause: Pending
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 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 call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: [email protected]. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.
Quantity in commerce: 14
Distribution: Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.
Product codes and lots: Part # Lot # 04.001.620S 7115414 04.001.620S 7115417 04.001.620S 7115509 04.001.620S 7115510 04.001.622S 7115533 04.001.636S 7117902 04.001.636S 7117916 04.001.638S 7117924 04.001.640S 7119089 04.001.640S 7119107 04.001.642S 7117995 04.001.642S 7119125 04.001.644S 7117998 04.001.218S 7327816 04.001.444S 7379241 04.001.620s 7265517

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0407-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0407-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

Product code JDS

K033071Class IISynthes (USA) Cannulated Titanium Humeral Nail SystemSynthes (Usa) / cleared 2003-11-05

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)