FDA-Device2016-06-22Class II

BioSync Anatomic Cotton Wedge, 20 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 products total
Manufactured in
1370 Creekside Blvd, Naples, FL, United States
Products
BioSync Anatomic Cotton Wedge, 20 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-1962-2016

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