Z-3167-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2017
- Initiation Date
- May 22, 2017
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,240 units
Product Description
ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.
Reason for Recall
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.
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.
Code Information
Lot Numbers: 63545289, 63545291, 63578158, 63326460, 63333735, 63333738, 63333802, 63340556, 63340559, 63340563, 63347073, 63347075, 63350786, 63350787, 63358205, 63358206, 63384637, 63384658, 63384660, 63398760, 63415294, 63415296, 63426493, 63444520, 63457643, 63457784, 63457785, 63457787, 63457791, 63457950, 63469922, 63469924, 63469933, 63474430, 63478998 & 63518034.