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Recall Observatory FDA recall evidence

Device product

28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122

Z-0314-2022

October 15, 2021

Class II

Product summary

Firm
Howmedica Osteonics Corp.
Event
Event 88964
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-0314-2022

Official wording

Reason: There is a potential for the outer white Tyvek lid to debond from the sealed package.

Code information: UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306

Distribution pattern: Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the outer white Tyvek lid to debond from the sealed package.