FDAFDA · Food and drugs·Recall number Z-1960-2016
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Published June 22, 2016 · Recall initiated: April 22, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for polystyrene particulate presence.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arthrex, Inc.
- Distributor
- Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
- Lot
- Catalog #: AR-8948W-1665; Batch #: 10020489; Unique Device Identifier: 00888867202726.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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