Recall Z-2918-2016— Arthrex, Inc.

Name: FDA recall Z-2918-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-12

Class III · Terminated

Class III FDA medical device recall by Arthrex, Inc., initiated 2016-08-12, terminated 2019-08-20. It names one FDA 510(k) clearance: K043145. Product: Arthrex Suture Washer. Reason: The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package..

Recalling firm: Arthrex, Inc.
Classification: Class III
Status: Terminated
Initiated: 2016-08-12
Terminated: 2019-08-20
Firm location: Naples, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K043145 — BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367BArthrex, Inc.·cleared 2005-02-18

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

Arthrex Suture Washer

Reason for recall

The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

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