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ST.A.R. 90 F4

CITIEFFE SRL · Model HA cortical bone screw ø6mm L180-50mm · UDI-DI 08032909624850

JDW Prescription
1
510(k) clearances
2,172
Adverse events (2 deaths)
100
Recalls
178
Facilities

Description

Cortical bone screw with hydroxyapatite coating ø6mm L180mm-Thread L50mm. Material: stainless steel AISI 316L (ASTM F138). Coating: hydroxyapatite (ASTM F1185, ASTM F1609). Bone screw tip not coated.

Recalls

DateFirmReason
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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
2018-09-27Orthofix SrlAs 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.