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DOLPHIX
CITIEFFE SRL · Model Pilon fractures kit · UDI-DI 08032909625055
1
510(k) clearances
2,172
Adverse events (2 deaths)
100
Recalls
178
Facilities
Description
Temporary external fixation kit composed of: - Clamp with bone screw ø 6mm L160mm (2 pcs); - Clamps with transfixing bone screw ø5mm L220mm (1 pc); - Rod to rod clamp (2 pcs); - Rod ø12mm L200mm (1 pc); - Rod ø12mm L280mm (2 pcs); - Hand drill (1 pc). Bone screw material: titanium alloy Ti6Al4V ELI (ASTM F136).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
| 2018-09-27 | Orthofix Srl | As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result i |
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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.