Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate
Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (foreign particulate in a surgical implant) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Arthrex, Inc. is recalling 138 units of the BioSync Anatomic Cotton Wedge, 16 x 4.5 mm. This medical device is used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot.
The recall was initiated due to the potential for polystyrene particulate presence in the product. The affected units are identified by Catalog # AR-8948W-1645, Batch # 10019815 & 10031866, and Unique Device Identifier 00888867202702.
The products were distributed in the states of California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, North Carolina, New York, Pennsylvania, South Carolina, Virginia, Washington, and Wisconsin. The source text does not specify specific actions for consumers or patients, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 138
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog #: AR-8948W-1645
- Batch #: 10019815 & 10031866
- Unique Device Identifier: 00888867202702.
Distribution
Part of a larger recall action
This product is one of 6 recalled by Arthrex, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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