Apex®

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.

Regulatory clearances

• None linked in the loaded window.

Manufacturer compliance record — Stryker GmbH

• 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