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Recall Observatory FDA recall evidence

Device product

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

Z-2219-2024

May 09, 2024

Class II

Product summary

Firm
Stryker GmbH
Event
Event 94721
Status
Ongoing
Classification
Class II
Quantity
39 devices
Official record key
device-enforcement:Z-2219-2024

Official wording

Reason: The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

Code information: Lot #J43995, UDI-DI 07613252611035.

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.