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Recall Observatory FDA recall evidence

Device product

ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

Z-1169-2023

February 02, 2023

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 91673
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-1169-2023

Official wording

Reason: Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.

Code information: GTIN 00840420152985, Lot Number 1636048

Distribution pattern: US Nationwide distribution in the state of NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.