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Terminated

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

FDA Recall Z-1012-2017 · Posted 2017-01-11

Recalling FirmSymmetry Surgical, Inc.
Recall StatusTerminated
Product CodeKCT
Date Initiated2016-11-29
Date Terminated2017-08-20
Product Quantity38 units

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.

Firm 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).

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113776FLASHPAKSymmetry Medical · 2012-08-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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