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Recall Observatory FDA recall evidence

Device product

APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

Z-1821-2024

April 12, 2024

Class II

Product summary

Firm
Medartis Inc.
Event
Event 94445
Status
Ongoing
Classification
Class II
Quantity
110 units
Official record key
device-enforcement:Z-1821-2024

Official wording

Reason: Screw is 16mm long instead of 22mm long.

Code information: Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.

Distribution pattern: Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Screw is 16mm long instead of 22mm long.