Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upp
FDA device recall Z-2207-2013 · posted 2013-09-16 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
- Action taken
- Biomet 3i sent an Urgent: Medical Device Recall letter dated June 10, 2013 to affected customer via email, facsimile, or postal mail. The letter identified the affected product, problem, and actions to be taking. Customer were instructed to check their respective inventory for the affected product and return to Biomet 3i. Biomet 3i will issue replacement product. For questions or concerns call 1-800-342-5454.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 215
- Distribution
- Worldwide Distribution - USA Nationwide in the states of MA, CT, NJ, DE, NY, FL, OK, TX, PA, DC, IL, KS, LA, MD, CA, RI, TN, MN, and SC and the countries of Canada, Japan, Australia, Italy Germany, Fr
- Date initiated
- 2013-06-10
- Date posted
- 2013-09-16
- Date terminated
- 2014-11-06
- 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 |
|---|---|---|
| OSSEOTITE II MODEL XIFOSSXXX (K100724) | Biomet 3i, Inc. | 2011-04-01 |