The Recall Desk
HighFDA (Devices)·Z-1723-2015·Announced 2015-06-17

Vilex FUZE Ankle Arthrodesis Screws Recalled for Breakage

Vilex, Inc. is recalling 4 units of FUZE 10.0 mm x 250 mm ankle arthrodesis screws due to a higher-than-expected incidence of breakage.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect (breakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Vilex, Inc. is recalling 4 units of FUZE 10.0 mm x 250 mm screws, Product # FZ100-250T-25. These medical devices are indicated for ankle arthrodesis and tibio-talo-calcaneal arthrodesis.

The recall was initiated because the incidence of breakage for these specific units is higher than expected. The affected products were distributed in the states of Mississippi, Maryland, Pennsylvania, and Texas.

Healthcare providers and patients should contact Vilex, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Vilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Manufacturer
Vilex In Tennessee Inc
Category
Medical Device — Orthopedic Screws
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all codes

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 3 recalled by Vilex In Tennessee Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

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Same hazard · breakage

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