Recall Z-1960-2016— Arthrex, Inc.

Name: FDA recall Z-1960-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-22

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2016-04-22, terminated 2017-10-13. It names one FDA 510(k) clearance: K151256. 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.. Reason: Potential for polystyrene particulate presence..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Terminated: 2017-10-13
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K151256 — Arthrex BioSync® Bone WedgeArthex, Inc.·cleared 2015-08-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Potential for polystyrene particulate presence.

Data sourced from openFDA. This site is unofficial and independent of the FDA.