FDA recall Z-1464-2018

Ace Surgical Supply Co., Inc. · Class II · device

Product

Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.

Reason for recall

The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.

Distribution

US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,

Key facts

Status
Terminated
Initiation date
2018-03-28
Report date
2018-05-02
Termination date
2018-09-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brockton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1464-2018