FDA-Device2016-06-22Class II
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Arthrex, Inc.
Hazard
Potential for polystyrene particulate presence.
Sold states
Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Affected count
138 total products
Manufactured in
1370 Creekside Blvd, Naples, FL, United States
Products
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1959-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief