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.
This recall has been terminated (originally issued April 22, 2016).
- Company
- Arthrex, Inc.
- Recall Initiated
- April 22, 2016
- Terminated
- October 13, 2017
- Recall Number
- Z-1963-2016
- Quantity
- 138 total products
- Firm Location
- Naples, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for polystyrene particulate presence.
Distribution
Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
Lot / Code Info
Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757.
Root Cause
Material/Component Contamination
Action Taken
On 04/22/2016 Arthrex contacted all distributors that received potentially affected devices and instructed them to place the product in quarantine. Distributors were then instructed to return affected devices to Arthrex. Surgeons who have implanted the device will also be receiving a recall notification. Surgeons, risk managers, and distributors received mailed recall notification identifying the recalled products and batches, the reason for recall, and instructions for returning affected product. Customers are to call Arthrex's Customer Service Line (800-934-4404) to obtain return authorization and further instructions. Customers were also required to complete a "Recall Acknowledgement of Receipt" postal card to return to Arthrex, Inc. in an enclosed envelope.