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12mm Narrow PPK Spacer Block
Model SSI005420 · Biomet Orthopedics, LLC · DI 00889024583313
HTJ — Gauge, Depth · Class I · 21 CFR 888.4300
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
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 (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
2.48
2019-02
0
2.33
2019-03
0
2.25
2019-04
0
2.05
2019-05
0
2.24
2019-06
0
2.3
2019-07
0
2.41
2019-08
0
2.21
2019-09
0
2.68
2019-10
0
2.12
2019-11
0
2.12
2019-12
0
2.32
2020-01
0
2.6
2020-02
0
2.1
2020-03
0
2.16
2020-04
0
2.38
2020-05
0
2.1
2020-06
0
2.64
2020-07
0
3.58
2020-08
0
3.34
2020-09
0
3.44
2020-10
0
4.03
2020-11
0
3.63
2020-12
0
3.56
2021-01
0
3.65
2021-02
0
3.54
2021-03
0
3.25
2021-04
0
3.41
2021-05
0
3.16
2021-06
0
3.07
2021-07
0
2.71
2021-08
0
3.19
2021-09
0
2.77
2021-10
0
2.53
2021-11
0
3.14
2021-12
0
2.72
2022-01
0
2.61
2022-02
0
3.11
2022-03
0
3.1
2022-04
0
3.45
2022-05
0
3.65
2022-06
0
2.82
2022-07
0
2.49
2022-08
0
2.56
2022-09
0
2.92
2022-10
0
3.23
2022-11
0
3.64
2022-12
0
3.66
2023-01
0
4.44
2023-02
0
3.19
2023-03
0
3.64
2023-04
0
3.13
2023-05
0
3.27
2023-06
0
3.14
2023-07
0
2.86
2023-08
0
2.9
2023-09
0
2.19
2023-10
0
2.39
2023-11
0
3.27
2023-12
0
2.95
2024-01
0
2.81
2024-02
0
2.99
2024-03
0
2.69
2024-04
0
3.59
2024-05
0
3.52
2024-06
0
3.6
2024-07
0
2.82
2024-08
0
2.7
2024-09
0
3.05
2024-10
0
3.04
2024-11
0
2.77
2024-12
0
2.53
2025-01
0
2.84
2025-02
0
4.13
2025-03
0
4.94
2025-04
0
2.75
2025-05
0
2.84
2025-06
0
2.81
2025-07
0
2.59
2025-08
0
2.6
2025-09
0
2.17
2025-10
0
2.35
2025-11
0
2.57
2025-12
0
3.74
2026-01
0
3.49
2026-02
0
3.49
2026-03
0
3.2
2026-04
0
3.06
2026-05
0
2.62
2026-06
0
3.29
This device (reports/month)Average device in HTJ, LXH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC