Recall Z-2165-2012— Smith & Nephew, Inc. Endoscopy Division

Name: FDA recall Z-2165-2012
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 Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618. 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 Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618

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.