CLASS II Device recall · Reported 17 Jun 2015 · FDA Enforcement Report

Vilex, Inc., FUZE, Product # FZ100-250T recalled by Vilex In Tennessee

Vilex In Tennessee is recalling Vilex, Inc., FUZE, Product # FZ100-250T-25, distributed in Maryland, Mississippi, Pennsylvania, Texas. The recall was initiated on 22 Apr 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes

Quantity recalled4 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1723-2015
FDA event ID: 71344
Recalling firm: Vilex In Tennessee, Mcminnville, TN
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2015
FDA classified: 8 Jun 2015
Reported: 17 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

22 Apr 2015	Recall initiated by company
8 Jun 2015	Classified by FDA	+47 days
17 Jun 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incidence of breakage is higher than expected.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

Where it was distributed

Distributed in the states of MS, MD, PA, and TX.

Maryland Mississippi Pennsylvania Texas

Questions about this recall

Why was it recalled?

Incidence of breakage is higher than expected.

Which lots are affected?

all codes

Where was it sold?

Distributed in the states of MS, MD, PA, and TX.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 71344

This product is part of a recall event; the main page for the event is Vilex, Inc., FUZE, Product # FZ100-200T recalled by Vilex In Tennessee.

Reported	Class	Recall	Company	Reason	Where
17 Jun 2015	CLASS II	Vilex, Inc., FUZE, Product # FZ100-200T recalled by Vilex In Tennessee	Vilex In Tennessee	Device Malfunction	4 states
17 Jun 2015	CLASS II	Vilex, Inc., FUZE, Product # FZ100-150T recalled by Vilex In Tennessee	Vilex In Tennessee	Device Malfunction	4 states

More recalls from Vilex In Tennessee

All 3

Reported	Class	Recall	Company	Reason	Where
17 Jun 2015Device	CLASS II	Vilex, Inc., FUZE, Product # FZ100-150T recalled by Vilex In Tennessee	Vilex In Tennessee	Device Malfunction	4 states
17 Jun 2015Device	CLASS II	Vilex, Inc., FUZE, Product # FZ100-200T recalled by Vilex In Tennessee	Vilex In Tennessee	Device Malfunction	4 states

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