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Recall Observatory FDA recall evidence

Device product

3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.

Z-2057-2018

December 21, 2017

Class II

Product summary

Firm
Stryker Corporation
Event
Event 79978
Status
Completed
Classification
Class II
Quantity
2 boxes (5 units per box)
Official record key
device-enforcement:Z-2057-2018

Official wording

Reason: Inadvertent shipment of expired units.

Code information: Lot No. 14239AG2, UPC 07613327055795. The expiration date marked on the box is August 2018, but it should be August 2016.

Distribution pattern: US distribution to Massachusetts only..

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inadvertent shipment of expired units.