Recall Z-1010-2017— Symmetry Surgical, Inc.

Name: FDA recall Z-1010-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-29

Class II · Terminated

Class II FDA medical device recall by Symmetry Surgical, Inc., initiated 2016-11-29, terminated 2017-08-20. It names one FDA 510(k) clearance: K113776. Product: symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container. Reason: Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization..

Recalling firm: Symmetry Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Terminated: 2017-08-20
Firm location: Antioch, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K113776 — FLASHPAKSymmetry Medical·cleared 2012-08-08

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

symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 Product Usage: sterilization container

Reason for recall

Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

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