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PAEDIATRIC LIMB RECONSTRUCTION SYSTEM

ORTHOFIX SRL · Model 1 · UDI-DI 18053504366331

JDW Prescription

510(k) clearances

2,172

Adverse events (2 deaths)

100

Recalls

178

Facilities

Description

Spare part, not medical device, not for sale. Reported for registration of UDI direct marking.

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.