Z-2243-2013Class II

Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant...

Name: Z-2243-2013 Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant...
Creator: Synthes USA HQ, Inc.
Published: 2013-04-18
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-04-18 / Terminated / root cause: packaging

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device on 2013-04-18. FDA classified it as Class II and gives the reason as "Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed". 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-2243-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-18
Posted: 2013-09-18
Terminated: 2015-03-30
Recalling firm: Synthes GmbH
Product: Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Product code: HTY Pin, Fixation, Smooth
Reason for recall: Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested.
Quantity in commerce: 1
Distribution: US distribution to MA.
Product codes and lots: Part Number 450.851S, Lot Number 7065061

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2243-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2243-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-18

Product code HTY

K970733Class IISynthes Titanium Diastal Femoral Nail (Ti Dfn) SystemSynthes (Usa) / cleared 1997-04-02

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)