Z-1010-2017Class II

symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854...

Name: Z-1010-2017 symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854...
Creator: Symmetry Surgical, Inc.
Published: 2016-11-29
License: https://open.fda.gov/license/

Symmetry Surgical GmbH / initiated 2016-11-29 / Terminated / root cause: manufacturing process

FDA source

Symmetry Surgical, Inc. began a recall of symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136... on 2016-11-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1010-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Posted: 2017-01-11
Terminated: 2017-08-20
Recalling firm: Symmetry Surgical GmbH
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
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent a Customer Safety Notice letter to customers. The letter identified the affected product problem and actions to be taken. Siemens Customer Service Engineer will contact customers to setup an appointment for installation of the new residual current monitor (RCM).
Quantity in commerce: 7613 units
Distribution: Worldwide Distribution
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1010-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11
Z-1011-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11
Z-1012-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code KCT

K113776Class IIFlashpakSymmetry Medical / cleared 2012-08-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)