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HA Bone Screws

ORTHOFIX SRL · Model 1 · UDI-DI 18032568039818

JDW Prescription

510(k) clearances

2,173

Adverse events (2 deaths)

100

Recalls

179

Facilities

Description

OSTEOTITE BONE SCREW 260/15 MM SHAFT D 6MM THREAD D 4.5-3.5MM

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.