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EXETER

Model 0920-2-920 · Howmedica Osteonics Corp. · DI 04546540166715

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

LZN — Cement Obturator · Class II · 21 CFR 878.3300

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 (3)

InitiatedRecall #ClassStatusReasonLink basis
2010-03-31Z-1593-2010TerminatedOne lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.k number procode
2010-03-31Z-1594-2010TerminatedOne lot of 13 mm medium distal ring centralizers and 14 mm large distal ring centralizer have been labeled incorrectly. The size 14 Large centralizers have been labeled as size 13 Medium centralizers and size 13 Medium centralizers have been labeled as size 14 Large centraliizers.k number procode
2010-03-29Z-1601-2010TerminatedStryker became aware that device labels have incorrectly printed manufacture dates and thus incorrect expiration dates on the product label.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.

12232019-01: 0 reports for this device; peer average 3.3/device2019-02: 0 reports for this device; peer average 2.65/device2019-03: 0 reports for this device; peer average 2.82/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 2.19/device2019-06: 0 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 2.01/device2019-08: 0 reports for this device; peer average 2.08/device2019-09: 0 reports for this device; peer average 2.42/device2019-10: 0 reports for this device; peer average 2.46/device2019-11: 0 reports for this device; peer average 1.96/device2019-12: 0 reports for this device; peer average 2.32/device2020-01: 0 reports for this device; peer average 2.63/device2020-02: 0 reports for this device; peer average 2.55/device2020-03: 0 reports for this device; peer average 3.32/device2020-04: 0 reports for this device; peer average 2.14/device2020-05: 0 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 1.89/device2020-07: 0 reports for this device; peer average 2.48/device2020-08: 0 reports for this device; peer average 1.89/device2020-09: 0 reports for this device; peer average 2.22/device2020-10: 0 reports for this device; peer average 2.44/device2020-11: 0 reports for this device; peer average 2.16/device2020-12: 0 reports for this device; peer average 2.16/device2021-01: 0 reports for this device; peer average 2.23/device2021-02: 0 reports for this device; peer average 1.95/device2021-03: 0 reports for this device; peer average 1.98/device2021-04: 0 reports for this device; peer average 1.88/device2021-05: 0 reports for this device; peer average 1.95/device2021-06: 0 reports for this device; peer average 2.35/device2021-07: 0 reports for this device; peer average 2.16/device2021-08: 0 reports for this device; peer average 1.92/device2021-09: 0 reports for this device; peer average 2.11/device2021-10: 0 reports for this device; peer average 1.98/device2021-11: 0 reports for this device; peer average 2.08/device2021-12: 0 reports for this device; peer average 2.28/device2022-01: 0 reports for this device; peer average 1.87/device2022-02: 0 reports for this device; peer average 2.34/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 2.13/device2022-05: 0 reports for this device; peer average 1.9/device2022-06: 0 reports for this device; peer average 2.02/device2022-07: 0 reports for this device; peer average 1.97/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 1.96/device2022-10: 0 reports for this device; peer average 1.99/device2022-11: 0 reports for this device; peer average 2.12/device2022-12: 0 reports for this device; peer average 2.02/device2023-01: 0 reports for this device; peer average 1.66/device2023-02: 0 reports for this device; peer average 1.87/device2023-03: 0 reports for this device; peer average 2.02/device2023-04: 0 reports for this device; peer average 1.93/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.11/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 2.02/device2023-09: 0 reports for this device; peer average 2.02/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1.54/device2023-12: 0 reports for this device; peer average 1.57/device2024-01: 0 reports for this device; peer average 1.62/device2024-02: 0 reports for this device; peer average 1.82/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 2.16/device2024-06: 0 reports for this device; peer average 1.88/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.96/device2024-10: 0 reports for this device; peer average 1.6/device2024-11: 0 reports for this device; peer average 1.48/device2024-12: 0 reports for this device; peer average 1.48/device2025-01: 0 reports for this device; peer average 1.55/device2025-02: 0 reports for this device; peer average 1.41/device2025-03: 0 reports for this device; peer average 1.63/device2025-04: 0 reports for this device; peer average 1.71/device2025-05: 0 reports for this device; peer average 1.44/device2025-06: 0 reports for this device; peer average 1.69/device2025-07: 0 reports for this device; peer average 1.64/device2025-08: 0 reports for this device; peer average 1.48/device2025-09: 0 reports for this device; peer average 1.77/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.55/device2026-03: 0 reports for this device; peer average 2.14/device2026-04: 0 reports for this device; peer average 1.79/device2026-05: 0 reports for this device; peer average 1.81/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.3
2019-0202.65
2019-0302.82
2019-0402.75
2019-0502.19
2019-0601.9
2019-0702.01
2019-0802.08
2019-0902.42
2019-1002.46
2019-1101.96
2019-1202.32
2020-0102.63
2020-0202.55
2020-0303.32
2020-0402.14
2020-0502.36
2020-0601.89
2020-0702.48
2020-0801.89
2020-0902.22
2020-1002.44
2020-1102.16
2020-1202.16
2021-0102.23
2021-0201.95
2021-0301.98
2021-0401.88
2021-0501.95
2021-0602.35
2021-0702.16
2021-0801.92
2021-0902.11
2021-1001.98
2021-1102.08
2021-1202.28
2022-0101.87
2022-0202.34
2022-0301.87
2022-0402.13
2022-0501.9
2022-0602.02
2022-0701.97
2022-0802.07
2022-0901.96
2022-1001.99
2022-1102.12
2022-1202.02
2023-0101.66
2023-0201.87
2023-0302.02
2023-0401.93
2023-0502.1
2023-0602.11
2023-0702.05
2023-0802.02
2023-0902.02
2023-1001.5
2023-1101.54
2023-1201.57
2024-0101.62
2024-0201.82
2024-0301.96
2024-0401.66
2024-0502.16
2024-0601.88
2024-0701.67
2024-0801.83
2024-0901.96
2024-1001.6
2024-1101.48
2024-1201.48
2025-0101.55
2025-0201.41
2025-0301.63
2025-0401.71
2025-0501.44
2025-0601.69
2025-0701.64
2025-0801.48
2025-0901.77
2025-1001.67
2025-1101.87
2025-1201.85
2026-0102
2026-0201.55
2026-0302.14
2026-0401.79
2026-0501.81
2026-0601.65
This device (reports/month)Average device in JDI, LZN (reports/device/month)

Regulatory clearances

  • K191414 SESE 2019-08-28 (k number procode)

Predicate lineage

K191414 — cites (transitively): K011623 (d1), K171768 (d1), K173499 (d1), K974054 (d1), K980843 (d1), K103479 (d2), K120578 (d2), K142462 (d2), K143085 (d2), K151264 (d2), K153345 (d2), K161569 (d2), K920868 (d2), K983382 (d2), K051741 (d2), K110290 (d2), K121308 (d2), K130610 (d2), K142295 (d2), K010757 (d3), K022077 (d3), K061434 (d3), K070885 (d3), K972228 (d3), K993601 (d3), K020572 (d3), K994366 (d3), K052639 (d3), K960658 (d3), K010170 (d3), K905258 (d3), K013676 (d3), K081171 (d3), K122853 (d3), K123604 (d3), K003379 (d3), K003391 (d3), K014226 (d3), K020497 (d3), K021310 (d3), K021911 (d3), K022555 (d3), K023102 (d3), K023901 (d3), K031730 (d3), K031744 (d3), K033716 (d3), K040412 (d3), K041170 (d3), K041940 (d3), K051588 (d3), K051737 (d3), K051738 (d3), K052718 (d3), K061654 (d3), K062419 (d3), K072020 (d3), K093644 (d3), K102019 (d3), K103233 (d3), K894124 (d3), K900836 (d3), K902365 (d3), K903362 (d3), K910988 (d3), K914406 (d3), K942809 (d3), K943549 (d3), K954077 (d3), K971409 (d3), K983226 (d3), K983502 (d3), K991952 (d3), K992570 (d3), P960047 (d3), K142606 (d3), K152304 (d3), K944213 (d3), K061067 (d4), K112802 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K041906 (d5), K042842 (d5), K052792 (d5), K070369 (d5), K094035 (d5), K102487 (d5), K072160 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K053340 (d5), K100391 (d5), K032396 (d6), K050327 (d6), K071535 (d6), K073102 (d6), K083762 (d6), K935484 (d6), K950827 (d6), K970501 (d6), K042871 (d6), K052888 (d6), K050539 (d6), K063423 (d6), K974556 (d6) — cited as predicate by K193429, K233498

K974054 — cited as predicate by K133370, K152084, K172857, K180973, K191414

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

Manufacturer compliance record — Howmedica Osteonics Corp.

  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • NAI 2021-06-22 Howmedica Osteonics Corp. · 0 citations
  • VAI 2015-03-09 Howmedica Osteonics Corp. · 3 citations
  • VAI 2013-04-16 Howmedica Osteonics Corp. · 3 citations
  • NAI 2010-01-15 Howmedica Osteonics Corp. · 0 citations