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ACM BioPrep

Model 0306708000 · STRYKER CORPORATION · DI 04546540055446

LZN — Cement Obturator · Class II · 21 CFR 878.3300

UDILibrary device dossier · generated 2026-09-14 · 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.

12232019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 1/device0203040708101205071112070905060809101101020406070809100103050810110102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302
2019-0402
2019-0701
2019-0801
2019-1003
2019-1202
2021-0503
2021-0703
2021-1101
2021-1201
2022-0703
2022-0902
2023-0503
2023-0601
2023-0801
2023-0901
2023-1002
2023-1102
2024-0101
2024-0202
2024-0402
2024-0601
2024-0701
2024-0801
2024-0902
2024-1001
2025-0101
2025-0302
2025-0501
2025-0802
2025-1001
2025-1101.5
2026-0101
2026-0201.5
2026-0302
2026-0402
2026-0501
This device (reports/month)Average device in LZN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations