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Recall Observatory FDA recall evidence

Device product

Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614

Z-1785-2024

March 29, 2024

Class II

Product summary

Firm
Stryker Leibinger GmbH & Co. KG
Event
Event 94367
Status
Ongoing
Classification
Class II
Quantity
63 units
Official record key
device-enforcement:Z-1785-2024

Official wording

Reason: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

Code information: GTIN: 07613327123197 Lot Number: 270644

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled