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.
This recall has been terminated (originally issued March 30, 2012).
- Company
- Straumann Usa Llc
- Recall Initiated
- March 12, 2012
- Posted
- March 30, 2012
- Terminated
- May 31, 2012
- Recall Number
- Z-1351-2012
- Quantity
- 346 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution.
Lot / Code Info
Lot No. CW642
Root Cause
Packaging process control
Action Taken
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.