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FlipCutter® III Drill
Model AR-1204FF · T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · DI 10818674021446
HTO — Reamer · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2020-01-20
Z-1542-2020
Class II
Terminated
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.
code info di
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.89
2019-02
0
1.38
2019-03
0
1.4
2019-04
0
1.43
2019-05
0
3
2019-06
0
3.23
2019-07
0
1.94
2019-08
0
4.47
2019-09
0
3.44
2019-10
0
3.31
2019-11
0
3.76
2019-12
0
4.07
2020-01
0
3.07
2020-02
0
3.11
2020-03
0
1.81
2020-04
0
1.35
2020-05
0
3.36
2020-06
0
1.4
2020-07
0
1.68
2020-08
0
2.89
2020-09
0
2.24
2020-10
0
2.91
2020-11
0
4.03
2020-12
0
4.95
2021-01
0
2.56
2021-02
0
3.25
2021-03
0
7.58
2021-04
0
6.11
2021-05
0
2.96
2021-06
0
10.58
2021-07
0
9.17
2021-08
0
6.3
2021-09
0
2.95
2021-10
0
7.23
2021-11
0
8.37
2021-12
0
5.81
2022-01
0
5.88
2022-02
0
4.1
2022-03
0
5.24
2022-04
0
2.56
2022-05
0
5.49
2022-06
0
3.81
2022-07
0
4.41
2022-08
0
4.51
2022-09
0
7.54
2022-10
0
6.75
2022-11
0
10
2022-12
0
3.91
2023-01
0
9.76
2023-02
0
5.79
2023-03
0
3.53
2023-04
0
2.84
2023-05
0
6.33
2023-06
0
7.64
2023-07
0
6
2023-08
0
10.31
2023-09
0
7.81
2023-10
0
7.13
2023-11
0
6.86
2023-12
0
4.27
2024-01
0
5.94
2024-02
0
18.12
2024-03
0
5.54
2024-04
0
9.95
2024-05
0
11.78
2024-06
0
6.74
2024-07
0
5.2
2024-08
0
4.32
2024-09
0
4.81
2024-10
0
2.9
2024-11
0
3.09
2024-12
0
2
2025-01
0
1.71
2025-02
0
1.29
2025-03
0
4
2025-04
0
1.28
2025-05
0
1.96
2025-06
0
2
2025-07
0
7.04
2025-08
0
2.79
2025-09
0
1.11
2025-10
0
1
2025-11
0
1.16
2025-12
0
1.74
2026-01
0
4.21
2026-02
0
2.52
2026-03
0
1.65
2026-04
0
13.87
2026-05
0
1.4
2026-06
0
1.95
This device (reports/month)Average device in HTO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION