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Recall Observatory FDA recall evidence

Device product

Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.

Z-0393-2022

December 03, 2021

Class II

Product summary

Firm
Wright Medical Technology Inc
Event
Event 89089
Status
Ongoing
Classification
Class II
Quantity
250 units
Official record key
device-enforcement:Z-0393-2022

Official wording

Reason: The incorrect product is contained in the packaging.

Code information: Lot #1643355

Distribution pattern: Worldwide distribution in the states of AZ, IA, ID, NC, NY, VA, and WV. The countries of Canada, France, Germany, Lebanon, The Netherlands, Saudi Arabia, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The incorrect product is contained in the packaging.