Recall Record

El Dorado Hills, CA, United States

Synvasive Technology Inc recalls

1 recall recorded since 2018, most recently on 27 July 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0

Terminated Class II Medical devices

Recall started
27 July 2018
Terminated
7 June 2021
Reason
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Distribution
US distribution to states of AL and NY
Initiated
Voluntary: Firm initiated
Recall number
Z-1676-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.