| Class 2 Device Recall FlipCutter III Drill | |
Date Initiated by Firm | January 20, 2020 |
Create Date | March 20, 2020 |
Recall Status1 |
Completed |
Recall Number | Z-1542-2020 |
Recall Event ID |
85019 |
Product Classification |
Reamer - Product Code HTO
|
Product | FlipCutter III Drill |
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 |
Recalling Firm/ Manufacturer |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. Kibbutz Gatton Naharia Israel
|
For Additional Information Contact | Shlomi Dines 239-5984302 Ext. 73219 |
Manufacturer 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. |
FDA Determined Cause 2 | Packaging process control |
Action | Consignees are instructed to return the affected devices which will be replaced. |
Quantity in Commerce | 6625 units |
Distribution | Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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