Arthrex, Inc.: BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

Recall number

Z-1960-2016

Recalling firm

Arthrex, Inc.

Product

BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.

Status

Terminated

Initiated

2016-04-22

Posted

not on file

Terminated

2017-10-13

Reason

Potential for polystyrene particulate presence.

Root cause

Material/Component Contamination

Action

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.

Quantity

138 total products

Distribution

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

Lot, serial or model codes

Catalog #: AR-8948W-1665; Batch #: 10020489; Unique Device Identifier: 00888867202726.

510(k) numbers

["K151256"]

PMA numbers

not on file

Product code

PLF

Firm FEI

1220246

Firm city

Naples

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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