Recall Z-2161-2012 ยท NHA Abutment, Implant, Dental, Endosseous
Straumann USA, LLC
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended fo
| Date | Aug 8, 2012 (initiated Jul 11, 2012) |
| Status | Terminated |
| Reason | Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2 |
| Root cause | Packaging process control |
| Action | Straumann notiifed accounts by telephone on July 10, 2012 and follow-up Field Safety Correction Action letter dated July 11, 2012, via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to discontinue use of the affected product and follow the instruction provided until replacement is received. For questions call 978-747-2514. |
| Quantity | 14 Distributed in US |
| Distribution | US Nationwide Distribution including the countries of FL, IN, LA, NY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081005 | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS Institut Straumann AG, May 2, 2008 |