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DFS HA BONE SCREWS
Model HAA60-13040 · Biomet Orthopedics, LLC · DI 00887868103810
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-12 · 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
2019-08-21
Z-0526-2020
Class II
Terminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
code info di
2019-08-21
Z-0528-2020
Class II
Terminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
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
2.04
2019-02
0
1.58
2019-03
0
1.6
2019-04
0
2.19
2019-05
0
1.69
2019-06
0
1.77
2019-07
0
2.07
2019-08
0
1.98
2019-09
0
1.71
2019-10
0
1.61
2019-11
0
1.83
2019-12
0
2.36
2020-01
0
2.42
2020-02
0
2.18
2020-03
0
1.81
2020-04
0
1.79
2020-05
0
1.66
2020-06
0
2.04
2020-07
0
2.51
2020-08
0
2.42
2020-09
0
2.43
2020-10
0
2.25
2020-11
0
2.62
2020-12
0
2.43
2021-01
0
1.8
2021-02
0
2.35
2021-03
0
2.6
2021-04
0
2.66
2021-05
0
2.5
2021-06
0
2.15
2021-07
0
2.18
2021-08
0
1.99
2021-09
0
2.29
2021-10
0
1.96
2021-11
0
2.35
2021-12
0
2.24
2022-01
0
2.81
2022-02
0
2.3
2022-03
0
2.02
2022-04
0
1.99
2022-05
0
2.54
2022-06
0
2.23
2022-07
0
2.17
2022-08
0
2.41
2022-09
0
2.82
2022-10
0
3
2022-11
0
3.06
2022-12
0
5.08
2023-01
0
2.74
2023-02
0
2.75
2023-03
0
2.94
2023-04
0
2.7
2023-05
0
3.27
2023-06
0
2.84
2023-07
0
2.26
2023-08
0
2.05
2023-09
0
2.05
2023-10
0
2.07
2023-11
0
1.83
2023-12
0
2.35
2024-01
0
2.65
2024-02
0
1.82
2024-03
0
2.21
2024-04
0
2.11
2024-05
0
2.19
2024-06
0
2.2
2024-07
0
2.35
2024-08
0
2.09
2024-09
0
2.06
2024-10
0
2.18
2024-11
0
2.01
2024-12
0
2.82
2025-01
0
2.14
2025-02
0
2.12
2025-03
0
2.01
2025-04
0
2.51
2025-05
0
2.42
2025-06
0
1.9
2025-07
0
2.1
2025-08
0
2.24
2025-09
0
2.02
2025-10
0
2.48
2025-11
0
2.02
2025-12
0
2.6
2026-01
0
2
2026-02
0
2.28
2026-03
0
2.48
2026-04
0
2.16
2026-05
0
2.61
2026-06
0
2.26
This device (reports/month)Average device in HWC, KTT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K081244 — cited as predicate by K102843, K111376
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC