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Flower E-Kit

FLOWER ORTHOPEDICS CORPORATION · Model EWK 200 · UDI-DI 00840118110846

JDW Prescription

510(k) clearances

2,180

Adverse events (2 deaths)

100

Recalls

179

Facilities

Description

Surgical instrument or accessory for orthopedic bone fixation. Includes Olive Wire, Guide Wire, screwdriver, depth gauge

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.