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ALLOCLASSIC® ZWEYMÜLLER® SL

Model 2845 · Zimmer GmbH · DI 00889024465589

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

KWL — Prosthesis, Hip, Hemi-, Femoral, Metal · Class II · 21 CFR 888.3360

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390

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

UDILibrary device dossier · generated 2026-09-16 · 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.

11232019-01: 0 reports for this device; peer average 2.61/device2019-02: 0 reports for this device; peer average 2.27/device2019-03: 0 reports for this device; peer average 2.52/device2019-04: 0 reports for this device; peer average 2.5/device2019-05: 0 reports for this device; peer average 1.98/device2019-06: 0 reports for this device; peer average 1.72/device2019-07: 0 reports for this device; peer average 1.72/device2019-08: 0 reports for this device; peer average 1.96/device2019-09: 0 reports for this device; peer average 2.03/device2019-10: 0 reports for this device; peer average 2.21/device2019-11: 0 reports for this device; peer average 1.89/device2019-12: 0 reports for this device; peer average 2.16/device2020-01: 0 reports for this device; peer average 2.51/device2020-02: 0 reports for this device; peer average 2.2/device2020-03: 0 reports for this device; peer average 2.79/device2020-04: 0 reports for this device; peer average 2.01/device2020-05: 0 reports for this device; peer average 2.04/device2020-06: 0 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 2.27/device2020-08: 0 reports for this device; peer average 1.84/device2020-09: 0 reports for this device; peer average 2.24/device2020-10: 0 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 2.02/device2020-12: 0 reports for this device; peer average 2.1/device2021-01: 0 reports for this device; peer average 2.16/device2021-02: 0 reports for this device; peer average 1.88/device2021-03: 0 reports for this device; peer average 1.89/device2021-04: 0 reports for this device; peer average 1.85/device2021-05: 0 reports for this device; peer average 1.87/device2021-06: 0 reports for this device; peer average 2.19/device2021-07: 0 reports for this device; peer average 2.13/device2021-08: 0 reports for this device; peer average 2.03/device2021-09: 0 reports for this device; peer average 2.21/device2021-10: 0 reports for this device; peer average 2.03/device2021-11: 0 reports for this device; peer average 1.91/device2021-12: 0 reports for this device; peer average 2.11/device2022-01: 0 reports for this device; peer average 1.88/device2022-02: 0 reports for this device; peer average 2.07/device2022-03: 0 reports for this device; peer average 1.91/device2022-04: 0 reports for this device; peer average 2.02/device2022-05: 0 reports for this device; peer average 2.01/device2022-06: 0 reports for this device; peer average 1.99/device2022-07: 0 reports for this device; peer average 1.94/device2022-08: 0 reports for this device; peer average 1.98/device2022-09: 0 reports for this device; peer average 2.01/device2022-10: 0 reports for this device; peer average 1.98/device2022-11: 0 reports for this device; peer average 2.06/device2022-12: 0 reports for this device; peer average 1.98/device2023-01: 0 reports for this device; peer average 2.12/device2023-02: 0 reports for this device; peer average 1.94/device2023-03: 0 reports for this device; peer average 2.02/device2023-04: 0 reports for this device; peer average 2.01/device2023-05: 0 reports for this device; peer average 2.01/device2023-06: 0 reports for this device; peer average 2.02/device2023-07: 0 reports for this device; peer average 1.95/device2023-08: 0 reports for this device; peer average 1.84/device2023-09: 0 reports for this device; peer average 1.88/device2023-10: 0 reports for this device; peer average 1.55/device2023-11: 0 reports for this device; peer average 1.53/device2023-12: 0 reports for this device; peer average 1.62/device2024-01: 0 reports for this device; peer average 1.64/device2024-02: 0 reports for this device; peer average 1.87/device2024-03: 0 reports for this device; peer average 1.85/device2024-04: 0 reports for this device; peer average 1.65/device2024-05: 0 reports for this device; peer average 1.96/device2024-06: 0 reports for this device; peer average 1.77/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.79/device2024-09: 0 reports for this device; peer average 1.85/device2024-10: 0 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 1.64/device2024-12: 0 reports for this device; peer average 1.53/device2025-01: 0 reports for this device; peer average 1.79/device2025-02: 0 reports for this device; peer average 1.47/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.78/device2025-05: 0 reports for this device; peer average 1.61/device2025-06: 0 reports for this device; peer average 1.77/device2025-07: 0 reports for this device; peer average 1.77/device2025-08: 0 reports for this device; peer average 1.64/device2025-09: 0 reports for this device; peer average 1.68/device2025-10: 0 reports for this device; peer average 1.7/device2025-11: 0 reports for this device; peer average 1.79/device2025-12: 0 reports for this device; peer average 1.82/device2026-01: 0 reports for this device; peer average 1.92/device2026-02: 0 reports for this device; peer average 1.59/device2026-03: 0 reports for this device; peer average 1.89/device2026-04: 0 reports for this device; peer average 1.85/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 1.66/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.61
2019-0202.27
2019-0302.52
2019-0402.5
2019-0501.98
2019-0601.72
2019-0701.72
2019-0801.96
2019-0902.03
2019-1002.21
2019-1101.89
2019-1202.16
2020-0102.51
2020-0202.2
2020-0302.79
2020-0402.01
2020-0502.04
2020-0601.84
2020-0702.27
2020-0801.84
2020-0902.24
2020-1002.25
2020-1102.02
2020-1202.1
2021-0102.16
2021-0201.88
2021-0301.89
2021-0401.85
2021-0501.87
2021-0602.19
2021-0702.13
2021-0802.03
2021-0902.21
2021-1002.03
2021-1101.91
2021-1202.11
2022-0101.88
2022-0202.07
2022-0301.91
2022-0402.02
2022-0502.01
2022-0601.99
2022-0701.94
2022-0801.98
2022-0902.01
2022-1001.98
2022-1102.06
2022-1201.98
2023-0102.12
2023-0201.94
2023-0302.02
2023-0402.01
2023-0502.01
2023-0602.02
2023-0701.95
2023-0801.84
2023-0901.88
2023-1001.55
2023-1101.53
2023-1201.62
2024-0101.64
2024-0201.87
2024-0301.85
2024-0401.65
2024-0501.96
2024-0601.77
2024-0701.63
2024-0801.79
2024-0901.85
2024-1001.67
2024-1101.64
2024-1201.53
2025-0101.79
2025-0201.47
2025-0301.75
2025-0401.78
2025-0501.61
2025-0601.77
2025-0701.77
2025-0801.64
2025-0901.68
2025-1001.7
2025-1101.79
2025-1201.82
2026-0101.92
2026-0201.59
2026-0301.89
2026-0401.85
2026-0501.67
2026-0601.66
This device (reports/month)Average device in JDI, KWL, KWY, LZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K030373 — cited as predicate by K100445, K170473, K193050

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

Manufacturer compliance record — Zimmer GmbH

  • Warning Letter 2016-05-27 Orthosoft, Inc.
  • Warning Letter 2012-09-19 Zimmer Manufacturing B.V.
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2020-10-01 Zimmer Manufacturing B.V. · 0 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
  • VAI 2017-07-27 ZIMMER ORTHOPEDIC MFG LTD · 3 citations
  • VAI 2017-07-20 Zimmer Manufacturing B.V. · 3 citations
  • VAI 2016-05-23 Zimmer Surgical Inc · 4 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • VAI 2015-11-17 Zimmer Manufacturing B.V. · 4 citations
  • VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
  • VAI 2014-10-16 ZIMMER ORTHOPEDIC MFG LTD · 2 citations
  • OAI 2014-06-11 Zimmer Manufacturing B.V. · 9 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • OAI 2013-08-19 Zimmer, Inc. · 0 citations