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External Mandibular Fixator And/Or Distractor
FDA product code MQN · Class 2 · Dental
2,275
Registered devices
1,416
Adverse events
9
Recalls
60
510(k) clearances
Devices with this code
DISTRACTION, INTERNAL — KLS-Martin L.P.DISTRACTION, INTERNAL, STERILE — KLS-Martin L.P.NA — Synthes GmbHLEVEL ONE CMF — KLS-Martin L.P.LEVEL ONE CMF — KLS-Martin L.P.NA — Synthes GmbHLEVEL ONE CMF — KLS-Martin L.P.NA — Synthes GmbHLEVEL ONE CMF — KLS-Martin L.P.NA — Synthes GmbHLEVEL ONE CMF — KLS-Martin L.P.OsteoMed — OSTEOMED LLCLEVEL ONE CMF — KLS-Martin L.P.DISTRACTION, INTERNAL — KLS-Martin L.P.LEVEL ONE CMF — KLS-Martin L.P.OsteoMed — OSTEOMED LLCLEVEL ONE CMF — KLS-Martin L.P.DISTRACTION SYSTEM — BIOMET MICROFIXATION, INCDISTRACTION, INTERNAL — KLS-Martin L.P.DISTRACTION, INTERNAL — KLS-Martin L.P.LEVEL ONE CMF — KLS-Martin L.P.LEVEL ONE CMF — KLS-Martin L.P.LEVEL ONE CMF — KLS-Martin L.P.NA — Synthes GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-05-23 | Synthes (USA) Products LLC | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separat |
| 2016-05-23 | Synthes (USA) Products LLC | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separat |
| 2016-05-23 | Synthes (USA) Products LLC | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separat |
| 2016-05-23 | Synthes (USA) Products LLC | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separat |
| 2016-05-23 | Synthes (USA) Products LLC | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separat |
| 2016-05-23 | Synthes (USA) Products LLC | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separat |
| 2014-10-17 | Synthes, Inc. | Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible Ext |
| 2014-04-16 | Synthes, Inc. | DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they |
| 2013-06-12 | Synthes USA HQ, Inc. | The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. |
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