—#111078

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.

FDA product code: NHA — Abutment, Implant, Dental, Endosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K081005
Affected lot / code info: 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;

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Straumann USA, LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

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

Timeline

Recall initiated: 2012-07-11
Posted by FDA: 2012-08-08
Terminated: 2012-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #111078. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.