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Recall Observatory FDA recall evidence

Device product

Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST

Z-0777-2020

November 11, 2019

Class II

Product summary

Firm
Nextremity Solutions
Event
Event 84405
Status
Terminated
Classification
Class II
Quantity
86 units
Official record key
device-enforcement:Z-0777-2020

Official wording

Reason: Components 2mm shorter than indicated on the package label

Code information: Lot Number: M1267 UDI: 00817701023166

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Components 2mm shorter than indicated on the package label