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.
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 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
- 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
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
Same manufacturer · Vilex In Tennessee Inc
See all →- HighVilex FUZE Ankle Arthrodesis Screws Recalled Due to Breakage
FDA (Devices) · 2015-06-17
- HighVilex FUZE Ankle Arthrodesis Screws Recalled for Breakage
FDA (Devices) · 2015-06-17
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