CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Ultra(R) Gravity container recalled by Symmetry Surgical

Symmetry Surgical is recalling symmetry surgical Ultra(R) Gravity container. The recall was initiated on 29 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll
Quantity recalled38 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1012-2017
FDA event ID
75850
Recalling firm
Symmetry Surgical, Antioch, TN
Classification
Class II
Status
Terminated
Recall initiated
29 Nov 2016
FDA classified
11 Jan 2017
Reported
18 Jan 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

29 Nov 2016Recall initiated by company
11 Jan 2017Classified by FDA+43 days
18 Jan 2017Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container

Where it was distributed

Worldwide Distribution

Questions about this recall

Is Ultra(R) Gravity container recalled?

Yes. Symmetry Surgical recalled Ultra(R) Gravity container on 29 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-1012-2017.

Why was it recalled?

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.

Which lots are affected?

All

Where was it sold?

Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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