Recall Z-1351-2012 ยท NDP Accessories, Implant, Dental, Endosseous
Straumann USA, LLC
Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. 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 placement and function on s
| Date | Mar 30, 2012 (initiated Mar 12, 2012) |
| Status | Terminated |
| Reason | Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN |
| Root cause | Packaging process control |
| Action | Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice. |
| Quantity | 346 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033922 | MODIFICATION TO ITI DENTAL IMPLANT SYSTEM Institut Straumann AG, Jan 7, 2004 |