The Recall Desk

FDA (Devices) recall action 87062

OMNIlife science Inc. recalled 3 products on 2021-02-03

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2021-02-03
Critical
0
Units
8

Why these products were recalled

Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery

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

1–3 of 3

  • HighFDA (Devices)··2021-02-03

    OmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits

    OmnIlife Science is recalling three units of SERF Novae Dual Mobility Cup Inserts because they exceed acceptable oxidation limits, potentially increasing wear rates and the need for revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
    Category
    Distribution
    5 states
  • SevereFDA (Devices)··2021-02-03

    OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation

    OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
    Category
    Distribution
    5 states
  • SevereFDA (Devices)··2021-02-03

    OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts

    OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.

    Product
    SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
    Category
    Distribution
    5 states