The Recall Desk

FDA (Devices) recall action 83760

Conformis, Inc. recalled 2 products on 2019-10-16

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
2019-10-16
Critical
0
Units
2

Why these products were recalled

Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-10-16

    Conformis Recalls iTotal Hip Replacement Stems Due to Packaging Error

    Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems because sizes 13 and 15 were packed in each other's packaging.

    Product
    iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2019-10-16

    Conformis iTotal Hip Replacement Stems Recalled for Packaging Error

    Conformis, Inc. is recalling two iTotal Hip Replacement femoral stems (sizes 13 and 15) because they were packed in each other's packaging.

    Product
    iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
    Category
    Distribution
    2 states