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52mm Single-Use Acetabular Reamer
Model 11-100-0052 · Osteofit LLC · DI 00850032869034
HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment · Class I · 21 CFR 878.4820
UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
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
2.57
2019-02
0
3.34
2019-03
0
3.74
2019-04
0
3.75
2019-05
0
4.47
2019-06
0
4.34
2019-07
0
3.28
2019-08
0
4.2
2019-09
0
4.39
2019-10
0
3.55
2019-11
0
4.17
2019-12
0
5.23
2020-01
0
3.83
2020-02
0
3.67
2020-03
0
5.43
2020-04
0
3.18
2020-05
0
3.39
2020-06
0
4.09
2020-07
0
3.35
2020-08
0
3.7
2020-09
0
4.4
2020-10
0
3.63
2020-11
0
4.26
2020-12
0
4.09
2021-01
0
3.41
2021-02
0
4.44
2021-03
0
4.14
2021-04
0
3.52
2021-05
0
4.14
2021-06
0
3.6
2021-07
0
3.14
2021-08
0
3.47
2021-09
0
2.94
2021-10
0
2.63
2021-11
0
3.19
2021-12
0
3.45
2022-01
0
2.89
2022-02
0
3.3
2022-03
0
3.73
2022-04
0
2.83
2022-05
0
3.4
2022-06
0
4.17
2022-07
0
3.03
2022-08
0
3.61
2022-09
0
4.98
2022-10
0
3.59
2022-11
0
4.13
2022-12
0
4.95
2023-01
0
2.81
2023-02
0
3.85
2023-03
0
3.68
2023-04
0
2.81
2023-05
0
4.17
2023-06
0
3.98
2023-07
0
3.25
2023-08
0
3.57
2023-09
0
3.49
2023-10
0
2.42
2023-11
0
4.39
2023-12
0
3.49
2024-01
0
2.91
2024-02
0
4.27
2024-03
0
3.3
2024-04
0
3.03
2024-05
0
4.22
2024-06
0
4.45
2024-07
0
2.76
2024-08
0
2.79
2024-09
0
4.14
2024-10
0
3
2024-11
0
2.93
2024-12
0
2.89
2025-01
0
2.91
2025-02
0
3.61
2025-03
0
3.28
2025-04
0
2.08
2025-05
0
4.03
2025-06
0
3.53
2025-07
0
2.85
2025-08
0
2.92
2025-09
0
2.57
2025-10
0
2.56
2025-11
0
4.02
2025-12
0
3.39
2026-01
0
2.42
2026-02
0
2.96
2026-03
0
3.04
2026-04
0
3.55
2026-05
0
3.26
2026-06
0
2.64
This device (reports/month)Average device in HWE (reports/device/month)