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.
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 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.
See all 6 products in this recall →Related recalls
Same manufacturer · Arthrex, Inc.
See all →- HighArthrex Small Joint OATS Sets recalled for incorrect reamer size packaging
FDA (Devices) · 2022-12-14
- HighK-Wire Devices Recalled for Incorrect Length and Diameter Specifications
FDA (Devices) · 2022-05-11
- HighSuture Anchor Products Recalled Due to Improper Sterilization
FDA (Devices) · 2021-07-28
- ModerateArthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
FDA (Devices) · 2021-04-21
- LowArthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator
FDA (Devices) · 2021-04-07
Same hazard · contamination
See all →- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 419 Surgical Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02