Device product
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Z-1963-2016
Product summary
- Firm
- Arthrex, Inc.
- Event
- Event 74084
- Status
- Terminated
- Classification
- Class II
- Quantity
- 138 total products
- Official record key
device-enforcement:Z-1963-2016
Official wording
Reason: Potential for polystyrene particulate presence.
Code information: Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757.
Distribution pattern: Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Derived failure modes
-
Foreign material or chemical contamination
particulate