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Recall Observatory FDA recall evidence

Device product

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

Z-1361-2022

October 07, 2021

Class II

Product summary

Firm
SCIENCE & BIO MATERIALS
Event
Event 90281
Status
Completed
Classification
Class II
Quantity
72 units
Official record key
device-enforcement:Z-1361-2022

Official wording

Reason: Mislabeled product.

Code information: Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled