—#108077

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.

FDA product code: NDP — Accessories, Implant, Dental, Endosseous
Device class: Class 1
Medical specialty: Dental
510(k) numbers: K033922
Affected lot / code info: Lot No. CW642

Why it was recalled

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 (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2012-03-12
Posted by FDA: 2012-03-30
Terminated: 2012-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.