Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate
Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.
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. The hazard involves potential particulate contamination in a medical device used for internal bone fixation, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Arthrex, Inc. is recalling 138 units of the BioSync Anatomic Cotton Wedge, 20 x 5.5 mm. This medical device is used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot. The recall is due to the potential for polystyrene particulate presence.
The affected products are identified by Catalog # AR-8948W-2055, Batch # 10019817, and Unique Device Identifier 00888867202740. The devices 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.
This is a Class II recall. Healthcare providers and patients should check their inventory or medical records for these specific lot numbers. If the device is currently implanted, patients should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- 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.
- Manufacturer
- Arthrex, Inc.
- 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-2055
- Batch #: 10019817
- Unique Device Identifier: 00888867202740.
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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