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STRYKER CORPORATION · Model 0946-044-001 · UDI-DI 07613327261233

INKFPO
10
510(k) clearances
4,228
Adverse events (3 deaths)
16
Recalls
20
Facilities

Description

Restraint Strap

Recalls

DateFirmReason
2020-04-07Stryker Medical Division of Stryker CorporationAmbulance Cots may not meet crash test standard BS EN 1789
2016-02-05Stryker Medical Division of Stryker CorporationThe hydraulic jack assemblies (PN: 0753-002-101, 0753-002-070, 0753-002-001, and 0753-002-001) were manufactured using the incorrect oil. The oil used does not contain the same wea
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2011-07-19Stryker Medical Division of Stryker CorporationStryker Medical has determined that some Prime Brake Pad Assembly components were manufactured with brake shoes that did not meet specifications. Accordingly some brake shoes used
2010-03-19Stryker Medical Div. of Stryker CorporationThe retractable cord stretchers were fitted with power cords, manufactured by Electri-Cord, whose prongs have the potential to fracture inside the molded section of the plug, causi

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.