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Recall Observatory FDA recall evidence

Device product

Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿

Z-2219-2021

May 12, 2021

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 88199
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2219-2021

Official wording

Reason: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Code information: Serial Numbers: G201179538 UDI: 07613327506129

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Brazil, Canada, Chile, Colombia, India, Mexico, Thailand.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals