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Zyphr
Model 5100060001 · STRYKER CORPORATION · DI 04546540716224
HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered) · Class II · 21 CFR 882.4305
UDILibrary device dossier · generated 2026-09-14 · 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
2020-10-16
Z-0431-2021
Class II
Terminated
Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.
code info di
Adverse-event reports — MAUDE (190)
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.
Injury: 109 · Malfunction: 81
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
1
2019-02
0
15.5
2019-03
7
29
2019-04
3
15
2019-05
6
11.67
2019-06
2
14.33
2019-07
7
10.33
2019-08
1
15.67
2019-09
2
8.2
2019-10
5
15.33
2019-11
3
14.67
2019-12
1
13.25
2020-01
0
22
2020-02
0
20
2020-03
0
20.5
2020-04
0
34
2020-05
4
6
2020-06
3
6.7
2020-07
1
7.57
2020-08
1
8.33
2020-09
8
10.4
2020-10
3
6.55
2020-11
4
10.33
2020-12
9
8.71
2021-01
3
6.67
2021-02
1
5.71
2021-03
2
7.4
2021-04
0
9.17
2021-05
5
7.67
2021-06
4
6.78
2021-07
0
6.2
2021-08
5
10.4
2021-09
2
11.8
2021-10
8
9.75
2021-11
4
5.5
2021-12
7
8.25
2022-01
1
15.5
2022-02
5
4.36
2022-03
5
8.14
2022-04
0
7.4
2022-05
0
6
2022-06
0
10.17
2022-07
3
14
2022-08
0
6.63
2022-09
0
14
2022-10
8
9.33
2022-11
2
8.17
2022-12
2
11.75
2023-01
1
10
2023-02
1
8.2
2023-03
0
8.25
2023-04
2
9
2023-05
3
10.75
2023-06
1
11.2
2023-07
0
9.67
2023-08
0
6.67
2023-09
1
6.4
2023-10
1
7.25
2023-11
0
14
2023-12
0
6.25
2024-01
0
14.75
2024-02
1
5.6
2024-03
0
7.75
2024-04
0
5.2
2024-05
2
3.6
2024-06
2
7
2024-07
1
5.17
2024-08
0
5
2024-09
0
8
2024-10
4
7.33
2024-11
1
3.8
2024-12
0
4.83
2025-01
1
5.4
2025-02
1
3
2025-03
3
4.2
2025-04
0
3.83
2025-05
1
2.6
2025-06
0
4.33
2025-07
1
6.25
2025-08
0
5.33
2025-09
1
3
2025-10
2
3.2
2025-11
0
3.43
2025-12
4
3
2026-01
1
3
2026-02
1
2.75
2026-03
4
2.6
2026-04
8
6
2026-05
2
3.33
2026-06
1
3
This device (reports/month)Average device in HBF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — STRYKER CORPORATION
Warning Letter 2017-04-06 Entellus Medical Inc.
Warning Letter 2015-04-08 Thermedx LLC
Injunction 2013-11-26 Physio-Control, Inc.
Warning Letter 2013-03-06 Stryker Corporation
Warning Letter 2013-03-06 Stryker Corporation
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