Recall Z-0174-2015 ยท DZE Implant, Endosseous, Root-Form
Straumann USA, LLC
Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: 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. Dental implants are intended for immediate pl
| Date | Nov 6, 2014 (initiated Sep 24, 2014) |
| Status | Terminated |
| Reason | Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) |
| Root cause | Packaging process control |
| Action | Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514. |
| Quantity | 111 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM Straumann USA, Jun 6, 2012 |