The Recall Desk

FDA (Devices) recall action 88964

Howmedica Osteonics Corp. recalled 2 products on 2021-12-08

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-12-08
Critical
0
Units
—

Why these products were recalled

XXX

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2021-12-08

    Orthopedic implant hip component recalled in Puerto Rico

    Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2021-12-08

    Orthopedic Implant Head Package Lid May Debond From Sealed Package

    Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
    Category
    Distribution
    1 state