Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25 recallZ-1721-2015 · Vilex In Tennessee Inc · initiated Apr 22, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Vilex In Tennessee Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incidence of breakage is higher than expected.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1721-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 22, 2015
- Posted by the FDA
- Jun 8, 2015
- Recalling firm
- Vilex In Tennessee Inc
- Quantity
- 13 units
- Product code
- HSB
- FDA submissions
- K102413
- Distribution
- Distributed in the states of MS, MD, PA, and TX.
Product description
Vilex, Inc., FUZE 10.0 mm x 150 mm, Product # FZ100-150T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Code information (models, lots, serial numbers)
all codes
Other devices under the same FDA submission
1 device cleared under K102413 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FUZE FZ120-200T-25Vilex LLC · Rod, Fixation, Intramedullary And Accessories1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71344).
- Z-1722-2015 · TerminatedVilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
- Z-1723-2015 · TerminatedVilex, Inc., FUZE 10.0 mm x 250 mm, Product # FZ100-250T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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