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aap Implantate AG · Model NK 1016-20 · UDI-DI 04042409048852

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

Description

K-wire with thread and trocar point, ø1.6, L 200

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.