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ST.A.R. 90 F4

CITIEFFE SRL · Model Cortical bone screw ø4mm L150-40mm · UDI-DI 08032909624317

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510(k) clearances

2,172

Adverse events (2 deaths)

100

Recalls

178

Facilities

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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Data 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.