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Recall Observatory FDA recall evidence

Device product

stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades

Z-1138-2025

January 08, 2025

Class II

Product summary

Firm
Stryker Corporation
Event
Event 96098
Status
Ongoing
Classification
Class II
Quantity
622 units
Official record key
device-enforcement:Z-1138-2025

Official wording

Reason: Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.

Code information: GTIN 04546540046482, Lot Number 22298017

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece.