The Recall Desk

FDA (Devices) recall action 64028

Exactech, Inc. recalled 2 products on 2013-02-13

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
2013-02-13
Critical
0
Units
52

Why these products were recalled

Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.

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

  • ModerateFDA (Devices)··2013-02-13

    Exactech Recalls Hip Replacement Liners Due to Labeling Error

    Exactech is recalling 26 hip replacement liners because the device labeling was inadvertently transposed. The units were distributed in five states.

    Product
    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Distribution
    5 states
  • ModerateFDA (Devices)··2013-02-13

    Exactech Recalls Novation Crown Cup Hip Liners Due to Labeling Error

    Exactech is recalling 26 units of Novation Crown Cup hip replacement liners because device labeling was inadvertently transposed.

    Product
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Distribution
    5 states