Recall Z-2045-2017— Arthrex, Inc.

Name: FDA recall Z-2045-2017
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 BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm. 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 BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm

Reason for recall

Some eyelets broke from SwiveLock Anchor on insertion.

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