Arthrex, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1963-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 22, 2016

Date Posted: June 22, 2016

Recall Number: Z-1963-2016

Event ID: 74084

Reason for Recall:

Potential for polystyrene particulate presence.

Status: Terminated

Product Quantity: 138 total products

Code Information:

Catalog #: AR-8948W-2065; Batch #: 10019150; Unique Device Identifier: 00888867202757.

Distribution Pattern:

Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated