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Recall Observatory FDA recall evidence

Device product

6381 M-1 Cot Fastener, catalog no. 6381000000

Z-1599-2018

March 09, 2018

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 79817
Status
Terminated
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-1599-2018

Official wording

Reason: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Code information: Serial No. 170740538 170740539 170740540

Distribution pattern: Product distributed to the Netherlands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.