The Recall Desk

FDA (Devices) recall action 71470

Omnilife Science Inc. recalled 2 products on 2015-09-02

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
2015-09-02
Critical
0
Units
30

Why these products were recalled

The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.

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)··2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
    Category
    Distribution
    4 states