Straumann Standard Plus Implant 04.8mm Wide Neck SLA 10mm Article Number: 043.652S. Dental implants are intended for sur
FDA device recall Z-1351-2012 · posted 2012-03-30 · Terminated
Recall details
- Recalling firm
- Straumann USA, LLC
- 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
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NDP
- Quantity affected
- 346 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-03-12
- Date posted
- 2012-03-30
- Date terminated
- 2012-05-31
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ITI DENTAL IMPLANT SYSTEM (K033922) | Institut Straumann AG | 2004-01-07 |