Device product
NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.
Z-3154-2017
Product summary
- Event
- Event 77417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 units
- Official record key
device-enforcement:Z-3154-2017
Official wording
Reason: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
Code information: Lot Numbers: 63385956, 63405774 & 63445667
Distribution pattern: Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Derived failure modes
-
Unknown
Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.