Vilex FUZE Ankle Arthrodesis Screws Recalled Due to Breakage
Vilex, Inc. is recalling 13 units of FUZE 10.0 mm x 150 mm ankle arthrodesis screws because the incidence of breakage is higher than expected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a risk-of-harm product (implant breakage) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria.
Plain-English summary
Vilex, Inc. is recalling 13 units of FUZE 10.0 mm x 150 mm screws, Product # FZ100-150T-25. These medical devices are indicated for ankle arthrodesis and tibio-talo-calcaneal arthrodesis. The recall was initiated because the incidence of breakage is higher than expected.
The affected units were distributed in the states of Mississippi, Maryland, Pennsylvania, and Texas. All codes are included in this recall.
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 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
- Manufacturer
- Vilex In Tennessee Inc
- Hazard
- Affected units
- 13
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
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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