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DISTRACTION, INTERNAL
KLS-Martin L.P. · Model 51-508-15-09 · UDI-DI 00888118099747
MQN
Prescription
10
510(k) clearances
1,416
Adverse events (3 deaths)
9
Recalls
30
Facilities
Description
DIST, SYMPHYSIS, ZURICH 1, BOLOGNA, 2.0-2.3 MM SCREW, TI-6AL-4V
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 separated from the Proximal |
| 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 separated from the Proximal |
| 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 separated from the Proximal |
| 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 separated from the Proximal |
| 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 separated from the Proximal |
| 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 separated from the Proximal |
| 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 External Fixator System |
| 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 may reverse post-ope |
| 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. There have been ins |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.