Recall Z-0117-2015 ยท DZE Implant, Endosseous, Root-Form
Straumann USA, LLC
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.
| Date | Oct 23, 2014 (initiated Sep 19, 2014) |
| Status | Terminated |
| Reason | Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) |
| Root cause | Packaging process control |
| Action | Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance. |
| Quantity | 6 units |
| Distribution | US Distribution in states of: FL and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT Straumann USA, LLC, Aug 20, 2014 |