Z-1721-2015Class II

Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal...

Name: Z-1721-2015 Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal...
Creator: Vilex In Tennessee Inc
Published: 2015-04-22
License: https://open.fda.gov/license/

Vilex LLC / initiated 2015-04-22 / Terminated / root cause: design

FDA source

Vilex In Tennessee Inc began a recall of Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis on 2015-04-22. FDA classified it as Class II and gives the reason as "Incidence of breakage is higher than expected". 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-1721-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Posted: 2015-06-08
Terminated: 2016-10-30
Recalling firm: Vilex LLC
Product: Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Incidence of breakage is higher than expected.
Root cause tag: design
FDA root cause: Device Design
Action: The initial telephone call (4/9/2015) informed the distributor that the product was on hold (not to be used or transferred). The second telephone call (4/29/2015) and letter informed the customer that the product was being removed from market and that the customer was to return the product to the corporate office. The letter was disseminated on 05/05/2015 to distributors via certified mail. The letter contains the instructions for them to follow, which as summarized are: inventory all products on hand, sign off on inventory sheet, send products back to the corporate office with the identified return number on the shipping container, inform the corporate office that the process has been completed and provide the corporate office with the list of the products returned. A second letter was disseminated to sales representatives (distributors), surgeons, and hospitals on 05/28/2015.
Quantity in commerce: 13 units
Distribution: Distributed in the states of MS, MD, PA, and TX.
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1721-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1721-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08
Z-1722-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08
Z-1723-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code HSB

K102413Class IIFuze: Intramedullary Internal Fixation NailVilex, Inc. / cleared 2011-11-14

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)