Recall Z-1822-2015— Smith & Nephew, Inc.

Name: FDA recall Z-1822-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-30

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2015-04-30, terminated 2017-09-19. It names one FDA 510(k) clearance: K132079. Product: ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.. Reason: Sterility of device maybe compromised.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-30
Terminated: 2017-09-19
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K132079 — TFCC FAST-FIX KITSmith & Nephew, Inc.·cleared 2013-12-05

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

ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.

Reason for recall

Sterility of device maybe compromised

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