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A.T.S.®
Model 60-4009-101-00 · ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. · DI 00889024376786
KCY — Tourniquet, Pneumatic · Class I · 21 CFR 878.5910
UDILibrary device dossier · generated 2026-09-13 · 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
2026-06-09
Z-2674-2026
Class II
Open, Classified
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.
code info di
Adverse-event reports — MAUDE (3)
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.
Malfunction: 3
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
1.33
2019-04
0
1.33
2019-05
0
2
2019-07
0
1.5
2019-10
0
1
2019-11
0
4
2020-01
0
2
2020-02
0
4
2020-03
0
1
2020-04
0
1.5
2020-06
0
1
2020-07
0
1
2020-10
0
1
2020-11
0
6
2021-01
0
1.33
2021-04
0
1
2021-06
0
1
2021-07
0
1.5
2021-09
0
1
2021-10
0
1
2021-11
0
2.67
2021-12
0
1
2022-01
0
1
2022-03
0
2.67
2022-04
0
1.17
2022-06
0
2.5
2022-07
0
1.33
2022-08
0
1
2022-09
0
1.25
2022-10
0
1.33
2022-12
0
2.17
2023-01
0
1.09
2023-02
0
1
2023-03
0
8.29
2023-04
0
3.33
2023-05
0
1.25
2023-06
0
4.88
2023-07
0
2
2023-08
2
1.5
2023-09
0
1.33
2023-10
0
1.67
2023-11
0
1
2023-12
0
1.67
2024-01
0
1.67
2024-02
0
1
2024-03
0
1
2024-04
0
1.5
2024-05
0
2
2024-06
0
1
2024-07
0
1.75
2024-08
0
1
2024-09
0
1.5
2024-10
0
1.8
2024-11
0
1.33
2024-12
0
3.4
2025-01
0
1.67
2025-02
0
5
2025-03
0
3.4
2025-04
0
1.2
2025-05
0
1.5
2025-06
0
2.5
2025-07
1
2
2025-08
0
2.25
2025-09
0
1
2025-10
0
1.5
2025-11
0
1
2026-01
0
1
2026-03
0
1
2026-04
0
1
2026-05
0
1
2026-06
0
1
This device (reports/month)Average device in KCY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.