Skip to content
Recall Observatory FDA recall evidence

Device 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

Z-1010-2017

November 29, 2016

Class II

Product summary

Firm
Symmetry Surgical, Inc.
Event
Event 75850
Status
Terminated
Classification
Class II
Quantity
7613 units
Official record key
device-enforcement:Z-1010-2017

Official wording

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.

Code information: All

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.