BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Recall
- Recall Number
- Z-1961-2016
- Event Number
- 74084
- Firm
- Arthrex, Inc.
- FEI Number
- 1220246
- Product Code
- PLF
- Status
- Terminated
- Root Cause
- Material/Component Contamination
- Initiated
- April 22, 2016
- Terminated
- October 13, 2017
- Address
- 1370 Creekside Blvd, Naples, FL, 34108-1945
Description
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
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.
Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
138 total products