Recall Z-2046-2014— Smith & Nephew, Inc. Endoscopy Division

Name: FDA recall Z-2046-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-02

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc. Endoscopy Division, initiated 2014-06-02, terminated 2017-09-15. It names one FDA 510(k) clearance: K122059. Product: SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue. Reason: Sterility of device is compromised due to breach in sterile barrier.

Recalling firm: Smith & Nephew, Inc. Endoscopy Division
Classification: Class II
Status: Terminated
Initiated: 2014-06-02
Terminated: 2017-09-15
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122059 — ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORSSmith & Nephew, Inc.·cleared 2013-03-18

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

SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue

Reason for recall

Sterility of device is compromised due to breach in sterile barrier

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