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BioZorb
Model F0221 · Hologic, Inc. · DI 15420045514027
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 (3)
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
2022-08-09
Z-1858-2022
Class II
Open, Classified
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.
code info di
Adverse-event reports — MAUDE (106)
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: 99 · Malfunction: 7
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
1
2.2
2021-12
0
2.43
2022-01
0
6.83
2022-02
0
2.14
2022-03
1
1.38
2022-04
0
2.27
2022-05
2
1.24
2022-06
2
2.2
2022-07
2
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
11
7.61
2023-10
6
3.63
2023-11
0
3.57
2023-12
2
2.4
2024-01
0
2
2024-02
0
2
2024-03
0
2.73
2024-04
2
3.53
2024-05
0
2.89
2024-06
0
1.82
2024-07
0
2.22
2024-08
2
7.25
2024-09
0
3.17
2024-10
12
7.86
2024-11
3
2.93
2024-12
0
3.07
2025-01
3
3.94
2025-02
3
3.78
2025-03
18
19.52
2025-04
3
11.18
2025-05
0
3.75
2025-06
6
5
2025-07
3
3.73
2025-08
3
5.5
2025-09
0
2.67
2025-10
0
1.62
2025-11
0
1.5
2025-12
3
2.89
2026-01
0
2.64
2026-02
0
2.1
2026-03
0
5.71
2026-04
0
2.38
2026-05
18
10.04
2026-06
0
2.2
This device (reports/month)Average device in NEU (reports/device/month)