Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.

FDA device recall Z-1722-2015 · posted 2015-06-08 · Terminated

Recall details

Recalling firm

Vilex In Tennessee Inc

Reason for recall

Incidence of breakage is higher than expected.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HSB

Quantity affected

7 units

Distribution

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

Date initiated

2015-04-22

Date posted

2015-06-08

Date terminated

2016-10-30

Location

Mcminnville, TN

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