Z-1351-2012

Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are...

Name: Z-1351-2012 Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are...
Creator: Straumann USA, LLC
Published: 2012-03-12
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2012-03-12 / Terminated / root cause: packaging

FDA source

Straumann USA, LLC began a recall of Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or... on 2012-03-12. The reason FDA records is "Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN". 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-1351-2012
Status: Terminated
Initiated: 2012-03-12
Posted: 2012-03-30
Terminated: 2012-05-31
Recalling firm: Straumann USA, LLC
Product: Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. 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. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: Mislabeled: Vial lid label on some of the dental implant vials from this lot incorrectly state 04.8 SP 10 RN instead of 04.8 SP 10 WN
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Straumann sent a "FIELD CORRECTIVE ACTION NOTICE" dated March 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. Additionally, a Customer Confirmation Form was enclosed for customers to complete and return. Contact the firm at 978-747-2514 for questions regarding this notice.
Quantity in commerce: 346 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot No. CW642

Product code NDP

K033922Class IIModification to Iti Dental Implant SystemInstitut Straumann AG / cleared 2004-01-07

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)