Straumann USA, LLC: Medical Device Recall in 2012 - (Recall #: Z-2161-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 11, 2012

Date Posted: August 15, 2012

Recall Number: Z-2161-2012

Event ID: 62575

Reason for Recall:

Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2

Status: Terminated

Product Quantity: 14 Distributed in US

Code Information:

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;

Distribution Pattern:

US Nationwide Distribution including the countries of FL, IN, LA, NY and TX.

Voluntary or Mandated:

Voluntary: Firm initiated