Preformance Post Dental implants
FDA device recall Z-2436-2016 · posted 2016-08-12 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Pouches may not have been sealed during packing.
- Action taken
- Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316. For questions regarding this recall call 561-776-6700.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- NHA
- Quantity affected
- 1,648,273 devices (all products subject to this recall)
- Distribution
- Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Cana
- Date initiated
- 2015-11-25
- Date posted
- 2016-08-12
- Date terminated
- 2019-07-26
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREFORMANCE POSTS AND TEMPORARY CYLINDERS (K061969) | Implant Innovations, Inc. | 2006-07-21 |