Z-2161-2012Class II

Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number...

Name: Z-2161-2012 Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number...
Creator: Straumann USA, LLC
Published: 2012-07-11
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2012-07-11 / Terminated / root cause: packaging

FDA source

Straumann USA, LLC began a recall of Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended... on 2012-07-11. FDA classified it as Class II and gives the reason as "Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2161-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-11
Posted: 2012-08-08
Terminated: 2012-09-05
Recalling firm: Straumann USA, LLC
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.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2
Root cause tag: packaging
FDA 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 in commerce: 14 Distributed in US
Distribution: US Nationwide Distribution including the countries of FL, IN, LA, NY and TX.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2161-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2161-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-08

Product code NHA

K081005Class IIP.004 Nc Cares Titanium and Ceramic AbutmentsInstitut Straumann AG / cleared 2008-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)