Z-1542-2020Class II

FlipCutter III Drill

Name: Z-1542-2020 FlipCutter III Drill
Creator: T.a.g. Medical Products Corporation, Ltd.
Published: 2020-01-20
License: https://open.fda.gov/license/

T.A.G. Medical Products Corporation Ltd / initiated 2020-01-20 / Terminated / root cause: packaging

FDA source

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. began a recall of FlipCutter III Drill on 2020-01-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1542-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-20
Posted: 2020-03-20
Terminated: 2025-04-21
Recalling firm: T.A.G. Medical Products Corporation Ltd
Product: FlipCutter III Drill
Product code: HTO Reamer
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.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1542-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1542-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-20

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)