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U.S. Department of Health and Human Services

Class 2 Device Recall FlipCutter III Drill

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 Class 2 Device Recall FlipCutter III Drillsee related information
Date Initiated by FirmJanuary 20, 2020
Create DateMarch 20, 2020
Recall Status1 Terminated 3 on April 21, 2025
Recall NumberZ-1542-2020
Recall Event ID 85019
Product Classification Reamer - Product Code HTO
ProductFlipCutter 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
FEI Number 1000272060
Recalling Firm/
Manufacturer		 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Kibbutz Gatton
Naharia Israel
For Additional Information ContactShlomi 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
ActionConsignees are instructed to return the affected devices which will be replaced.
Quantity in Commerce6625 units
DistributionProduct distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.
Total Product Life CycleTPLC Device Report
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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