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BioZorb
Model F0404 · Hologic, Inc. · DI 15420045514058
NEU — Marker, Radiographic, Implantable · Class II · 21 CFR 878.4300
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2024-10-10
Z-0328-2025
Class I
Open, Classified
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
code info di
2024-03-13
Z-1733-2024
Class I
Open, Classified
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device
code info di
Adverse-event reports — MAUDE (46)
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: 46
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
1.21
2019-02
0
1.67
2019-03
0
1.75
2019-04
0
2
2019-05
0
1.33
2019-07
0
1.75
2019-08
0
2.82
2019-09
0
2
2019-10
0
2
2019-11
0
1.83
2019-12
0
2
2020-01
0
1.6
2020-02
0
1.67
2020-03
0
3
2020-04
0
1.83
2020-05
0
3
2020-06
0
4
2020-07
0
2
2020-09
0
1
2020-10
0
1.5
2020-11
0
1.6
2020-12
0
1.75
2021-01
0
1
2021-02
0
2
2021-03
0
1.5
2021-04
0
2.71
2021-05
0
2.22
2021-06
0
1
2021-07
0
4.5
2021-08
0
1.6
2021-09
0
7.5
2021-10
0
1.44
2021-11
0
2.2
2021-12
0
2.43
2022-01
0
6.83
2022-02
0
2.14
2022-03
0
1.38
2022-04
0
2.27
2022-05
0
1.24
2022-06
0
2.2
2022-07
0
3
2022-08
0
1.8
2022-09
0
2.6
2022-10
0
1.86
2022-11
0
1.3
2022-12
0
1.5
2023-01
0
1.4
2023-02
0
2.27
2023-03
0
1.91
2023-04
0
1.67
2023-05
0
2
2023-06
0
6.67
2023-07
0
3.5
2023-08
0
1.14
2023-09
8
7.61
2023-10
0
3.63
2023-11
0
3.57
2023-12
0
2.4
2024-01
0
2
2024-02
0
2
2024-03
0
2.73
2024-04
0
3.53
2024-05
0
2.89
2024-06
0
1.82
2024-07
0
2.22
2024-08
3
7.25
2024-09
0
3.17
2024-10
3
7.86
2024-11
0
2.93
2024-12
0
3.07
2025-01
5
3.94
2025-02
2
3.78
2025-03
3
19.52
2025-04
9
11.18
2025-05
3
3.75
2025-06
0
5
2025-07
0
3.73
2025-08
1
5.5
2025-09
0
2.67
2025-10
2
1.62
2025-11
0
1.5
2025-12
0
2.89
2026-01
0
2.64
2026-02
0
2.1
2026-03
0
5.71
2026-04
0
2.38
2026-05
7
10.04
2026-06
0
2.2
This device (reports/month)Average device in NEU (reports/device/month)