FDA Device recall Z-2161-2012
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental impl…
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental impl… by Straumann Usa, citing incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2161-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-11 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
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 for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
Reason
Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2
Identifiers
| code_info | 26217US_10008_00_b00; 25262US_10115_00_b05; 25262US_10115_00_b06; 21408US_10073_00_b01; 26199US _10021_00_b00; 251…26217US_10008_00_b00; 25262US_10115_00_b05; 25262US_10115_00_b06; 21408US_10073_00_b01; 26199US _10021_00_b00; 25143US_ 10215_00_ b01; 25267US_10278- 00_ b01; 25267US _10280_ 00_b01; 25267US_ 1280_ 00_b03; 25310US_10342_03_b01; 25310US_10342_03_b03; 25310US_10342_03_b05; 25310US_10345_00_b01; 26249US_10019_00_b01; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2161-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.