Recall Z-2046-2017— Arthrex, Inc.

Name: FDA recall Z-2046-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-24

Class II · Terminated

Class II FDA medical device recall by Arthrex, Inc., initiated 2017-03-24, terminated 2019-11-04. It names one FDA 510(k) clearance: K101823. Product: Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching. Reason: Some eyelets broke from SwiveLock Anchor on insertion..

Recalling firm: Arthrex, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-24
Terminated: 2019-11-04
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K101823 — ARTHREX SWIVELOCK ANCHORSArthrex, Inc.·cleared 2011-01-07

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

Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching

Reason for recall

Some eyelets broke from SwiveLock Anchor on insertion.

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