Z-1542-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- January 20, 2020
- Termination Date
- April 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6625 units
Product Description
FlipCutter III Drill
Reason for Recall
There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.
Distribution Pattern
Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
Code Information
UDI: 10818674021446 Part Number: AR-1204FF Lots: 19E01, 19E02, 19E03, 19E05, 19E10, 19E11, 19F01, 19F02, 19F03, 19F04, 19F05, 19F06, 19F07, 19F08, 19F09, 19F10, 19J15, 19J16, 19J17, 19J18, 19J19, 19J20, 19J21, 19J22, 19J23, 19J24, 19J25, 19J26, 19J28, 19J29, 19K01, 19K02, 19K03, 19K09, 19K11, 19K12, 19M01, 19M09, 19M10, 19M11, 19M12, 19M13, 19M14, 19M15, 19M16, 19M17, 19M18, 19M21, 19M22, 19N02, 19N03, 19N05, 19N06, 19N07, 19N08, 19N09, 19N11, 19N12, 19N13, 19N14, 19P01, 19P02, 19P03, 19P04, 19P05, 19P06, 19P07, 19P08, 19P09, 19P10, 19P11, 19P12, 19P13, 19R01, 19R02, 19R04, 19R05, 19R06, 19R07