Device product
ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orthopedic surgical instrument.
Z-3156-2017
Product summary
- Event
- Event 77417
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
device-enforcement:Z-3156-2017
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 Number: 63517946
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.