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BONE SCREWS

Model Self Tapping · LIMACORPORATE SPA · DI 08033390123006

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

MBL — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous · Class II · 21 CFR 888.3358

UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (2)

InitiatedRecall #ClassStatusReasonLink basis
2021-10-01Z-0159-2022Class IITerminatedThere is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.k number procode
2021-10-01Z-0160-2022Class IITerminatedThere is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.k number procode

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.

12332019-01: 0 reports for this device; peer average 3.21/device2019-02: 0 reports for this device; peer average 2.72/device2019-03: 0 reports for this device; peer average 3.16/device2019-04: 0 reports for this device; peer average 2.94/device2019-05: 0 reports for this device; peer average 2.27/device2019-06: 0 reports for this device; peer average 1.93/device2019-07: 0 reports for this device; peer average 1.91/device2019-08: 0 reports for this device; peer average 2.27/device2019-09: 0 reports for this device; peer average 2.56/device2019-10: 0 reports for this device; peer average 2.84/device2019-11: 0 reports for this device; peer average 2.4/device2019-12: 0 reports for this device; peer average 2.72/device2020-01: 0 reports for this device; peer average 3.16/device2020-02: 0 reports for this device; peer average 2.71/device2020-03: 0 reports for this device; peer average 3.49/device2020-04: 0 reports for this device; peer average 2.46/device2020-05: 0 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 2.3/device2020-07: 0 reports for this device; peer average 2.75/device2020-08: 0 reports for this device; peer average 2.2/device2020-09: 0 reports for this device; peer average 2.83/device2020-10: 0 reports for this device; peer average 2.82/device2020-11: 0 reports for this device; peer average 2.54/device2020-12: 0 reports for this device; peer average 2.56/device2021-01: 0 reports for this device; peer average 2.73/device2021-02: 0 reports for this device; peer average 2.26/device2021-03: 0 reports for this device; peer average 2.26/device2021-04: 0 reports for this device; peer average 2.28/device2021-05: 0 reports for this device; peer average 2.18/device2021-06: 0 reports for this device; peer average 2.73/device2021-07: 0 reports for this device; peer average 2.62/device2021-08: 0 reports for this device; peer average 2.65/device2021-09: 0 reports for this device; peer average 2.73/device2021-10: 0 reports for this device; peer average 2.45/device2021-11: 0 reports for this device; peer average 2.27/device2021-12: 0 reports for this device; peer average 2.57/device2022-01: 0 reports for this device; peer average 2.32/device2022-02: 0 reports for this device; peer average 2.21/device2022-03: 0 reports for this device; peer average 2.49/device2022-04: 0 reports for this device; peer average 2.33/device2022-05: 0 reports for this device; peer average 2.36/device2022-06: 0 reports for this device; peer average 2.48/device2022-07: 0 reports for this device; peer average 2.3/device2022-08: 0 reports for this device; peer average 2.37/device2022-09: 0 reports for this device; peer average 2.41/device2022-10: 0 reports for this device; peer average 2.38/device2022-11: 0 reports for this device; peer average 2.47/device2022-12: 0 reports for this device; peer average 2.51/device2023-01: 0 reports for this device; peer average 2.59/device2023-02: 0 reports for this device; peer average 2.44/device2023-03: 0 reports for this device; peer average 2.71/device2023-04: 0 reports for this device; peer average 2.51/device2023-05: 0 reports for this device; peer average 2.4/device2023-06: 0 reports for this device; peer average 2.47/device2023-07: 0 reports for this device; peer average 2.3/device2023-08: 0 reports for this device; peer average 2.09/device2023-09: 0 reports for this device; peer average 2.07/device2023-10: 0 reports for this device; peer average 1.83/device2023-11: 0 reports for this device; peer average 1.77/device2023-12: 0 reports for this device; peer average 1.9/device2024-01: 0 reports for this device; peer average 1.87/device2024-02: 0 reports for this device; peer average 2.23/device2024-03: 0 reports for this device; peer average 2.02/device2024-04: 0 reports for this device; peer average 1.89/device2024-05: 0 reports for this device; peer average 2.18/device2024-06: 0 reports for this device; peer average 2.02/device2024-07: 0 reports for this device; peer average 1.84/device2024-08: 0 reports for this device; peer average 1.99/device2024-09: 0 reports for this device; peer average 2.17/device2024-10: 0 reports for this device; peer average 1.93/device2024-11: 0 reports for this device; peer average 1.97/device2024-12: 0 reports for this device; peer average 1.68/device2025-01: 0 reports for this device; peer average 2.14/device2025-02: 0 reports for this device; peer average 1.64/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.92/device2025-05: 0 reports for this device; peer average 1.91/device2025-06: 0 reports for this device; peer average 1.95/device2025-07: 0 reports for this device; peer average 1.95/device2025-08: 0 reports for this device; peer average 1.89/device2025-09: 0 reports for this device; peer average 1.81/device2025-10: 0 reports for this device; peer average 1.83/device2025-11: 0 reports for this device; peer average 1.86/device2025-12: 0 reports for this device; peer average 1.99/device2026-01: 0 reports for this device; peer average 2.05/device2026-02: 0 reports for this device; peer average 1.77/device2026-03: 0 reports for this device; peer average 1.98/device2026-04: 0 reports for this device; peer average 2.01/device2026-05: 0 reports for this device; peer average 1.81/device2026-06: 0 reports for this device; peer average 1.86/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.21
2019-0202.72
2019-0303.16
2019-0402.94
2019-0502.27
2019-0601.93
2019-0701.91
2019-0802.27
2019-0902.56
2019-1002.84
2019-1102.4
2019-1202.72
2020-0103.16
2020-0202.71
2020-0303.49
2020-0402.46
2020-0502.36
2020-0602.3
2020-0702.75
2020-0802.2
2020-0902.83
2020-1002.82
2020-1102.54
2020-1202.56
2021-0102.73
2021-0202.26
2021-0302.26
2021-0402.28
2021-0502.18
2021-0602.73
2021-0702.62
2021-0802.65
2021-0902.73
2021-1002.45
2021-1102.27
2021-1202.57
2022-0102.32
2022-0202.21
2022-0302.49
2022-0402.33
2022-0502.36
2022-0602.48
2022-0702.3
2022-0802.37
2022-0902.41
2022-1002.38
2022-1102.47
2022-1202.51
2023-0102.59
2023-0202.44
2023-0302.71
2023-0402.51
2023-0502.4
2023-0602.47
2023-0702.3
2023-0802.09
2023-0902.07
2023-1001.83
2023-1101.77
2023-1201.9
2024-0101.87
2024-0202.23
2024-0302.02
2024-0401.89
2024-0502.18
2024-0602.02
2024-0701.84
2024-0801.99
2024-0902.17
2024-1001.93
2024-1101.97
2024-1201.68
2025-0102.14
2025-0201.64
2025-0301.86
2025-0401.92
2025-0501.91
2025-0601.95
2025-0701.95
2025-0801.89
2025-0901.81
2025-1001.83
2025-1101.86
2025-1201.99
2026-0102.05
2026-0201.77
2026-0301.98
2026-0402.01
2026-0501.81
2026-0601.86
This device (reports/month)Average device in LPH, LZO, MBL (reports/device/month)

Regulatory clearances

  • K172456 SESE 2018-01-04 (k number procode)

Predicate lineage

K172456 — cites (transitively): K080642 (d1), K091508 (d1), K110598 (d1), K112898 (d1), K113121 (d1), K113254 (d1), K133349 (d1), K141395 (d1), K161120 (d1), K161742 (d1), K161863 (d1), K163397 (d1), K021891 (d2), K070369 (d2), K072154 (d2), K102975 (d2), K850766 (d2), K851213 (d2), K934765 (d2), K953490 (d2), K960094 (d2), K974093 (d2), K974095 (d2), K052906 (d2), K081059 (d2), K110708 (d2), K062113 (d2), K103835 (d2), K112144 (d2), K130895 (d2), K133834 (d2), K030710 (d2), K060694 (d2), K071090 (d2), K130642 (d2), K142139 (d2), K153722 (d2), K070479 (d3), K052472 (d3), K060988 (d3), K950521 (d3), K962082 (d3), K990598 (d3), K992065 (d3), K053274 (d3), K081016 (d3), K091751 (d3), K100858 (d3), K101263 (d3), K111212 (d3), K113523 (d3), K110847 (d3), K030259 (d4), K063578 (d4), K992525 (d4), K000575 (d4) — cited as predicate by K181491, K183042, K201905

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — LIMACORPORATE SPA

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