Recall Z-1012-2017 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Symmetry Surgical, Inc.
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
| Date | Jan 11, 2017 (initiated Nov 29, 2016) |
| Status | Terminated |
| 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. |
| 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 | 38 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113776 | FLASHPAK Symmetry Medical, Aug 8, 2012 |