OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
FDA device recall Z-1411-2015 · posted 2015-04-10 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
- Action taken
- Biomet 3i sent an URGENT MEDICAL DEVICE RECALL NOTICE dated November 7, 3014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
- Root cause
- Manufacturing material removal
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 620 implants in total
- Distribution
- Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austri
- Date initiated
- 2014-11-07
- Date posted
- 2015-04-10
- Date terminated
- 2015-05-22
- 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 |
|---|---|---|
| CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS (K130949) | Biomet 3i | 2013-07-30 |