BioSync Anatomic Cotton Wedge recall: Particulate Matter
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.
Why was BioSync Anatomic Cotton Wedge recalled?
Potential for polystyrene particulate presence.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757.
- 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.
- Recalling firm
- Arthrex, Inc.
- Quantity
- 138 total products
- Distribution
- Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
- Recall date
- June 22, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)