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Recall Observatory FDA recall evidence

Device product

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

Z-0645-2022

December 21, 2021

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 89456
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0645-2022

Official wording

Reason: There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Code information: UDI: 07613327013306; Lot Number: 87458602

Distribution pattern: Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the outer Tyvek lid to de-bond from the sealed package.