Mandibular Condyle Prosthesis
FDA product code MPL · Class III (high risk) · 21 CFR 872.3960 · Dental
PMA to be filed by 3/30/99 (63 FR 71746 (12/30/98))
0510(k) clearances
0PMA approvals
2recalls
Implantimplanted device
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0823-2012 | The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular…Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part #… | Biomet Microfixation, Inc. | 04/07/2010Terminated |
| Z-0822-2012 | The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint…Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part #… | Biomet Microfixation, Inc. | 04/07/2010Terminated |