Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence
Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device with a potential contamination hazard (polystyrene particulate) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Arthrex, Inc. is recalling 138 units of the BioSync Anatomic Cotton Wedge, 20 x 6.5 mm. This medical device is used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot.
The recall is being conducted due to the potential for polystyrene particulate presence in the devices. The specific catalog number is AR-8948W-2065, batch number 10019150, and the Unique Device Identifier is 00888867202757.
The affected 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. Healthcare providers and patients should contact Arthrex, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- 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.
- 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-2065
- Batch #: 10019150
- Unique Device Identifier: 00888867202757.
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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