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AVAflex

Model 1025011500 · STRYKER CORPORATION · DI 07613327374629

OAR — Injector, Vertebroplasty (Does Not Contain Cement) · Class I · 21 CFR 888.4200

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2024-06-03Z-2260-2024Class IIOpen, ClassifiedExpired Products distributed to customerscode info di

Adverse-event reports — MAUDE (10)

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.

Malfunction: 9 · Injury: 1

13452019-01: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-04: 1 reports for this device; peer average 1/device2020-07: 1 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-07: 1 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.5/device2023-04: 0 reports for this device; peer average 1/device2023-10: 1 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 5/device2024-04: 1 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/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 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-04: 1 reports for this device; peer average 1/device2025-07: 1 reports for this device; peer average 1/device2025-10: 1 reports for this device; peer average 1/device2026-01: 1 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2/device2026-04: 1 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1.5/device0103040506071003040710110104071001020307081001041011010405060708091011010203040710010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0304
2019-0401
2019-0501
2019-0601
2019-0701
2019-1001
2020-0301
2020-0411
2020-0711
2020-1001
2020-1101
2021-0101
2021-0401
2021-0701
2021-1002
2022-0102
2022-0201
2022-0301
2022-0711
2022-0801
2022-1001
2023-0101.5
2023-0401
2023-1011
2023-1101
2024-0105
2024-0411
2024-0501
2024-0601
2024-0701
2024-0801
2024-0901
2024-1001
2024-1101
2025-0101
2025-0201
2025-0301
2025-0411
2025-0711
2025-1011
2026-0111
2026-0201
2026-0302
2026-0411
2026-0502
2026-0601.5
This device (reports/month)Average device in OAR (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