Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, ...
FDA Recall #Z-0652-2014 — Class II — December 9, 2013
Product Description
Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
Reason for Recall
A sharp edge on the cannulated tip of the device may damage or cut a suture.
Recalling Firm
ArthroCare Medical Corporation — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
76
Distribution
Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.
Code Information
Catalog #25-3011, Lot #1049402
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated