Recall Z-2168-2012— Smith & Nephew, Inc. Endoscopy Division

Name: FDA recall Z-2168-2012
Creator: U.S. Food and Drug Administration
Published: 2012-07-03

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc. Endoscopy Division, initiated 2012-07-03, terminated 2016-04-18. It names one FDA 510(k) clearance: K100159. Product: Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone. Reason: Distal part of the anchor may break on insertion into bone during surgery.

Recalling firm: Smith & Nephew, Inc. Endoscopy Division
Classification: Class II
Status: Terminated
Initiated: 2012-07-03
Terminated: 2016-04-18
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K100159 — SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHORSmith & Nephew Inc., Endoscopy Div.·cleared 2010-04-19

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

Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone

Reason for recall

Distal part of the anchor may break on insertion into bone during surgery

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