The Recall Desk

FDA (Devices) recall action 68898

Ortho Development Corporation recalled 5 products on 2014-08-27

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2014-08-27
Critical
0
Units
227

Why these products were recalled

Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.

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.

1–5 of 5

  • SevereFDA (Devices)··2014-08-27

    Ortho Development Recalls Knee Implant Components Due to Sealing Defects

    Ortho Development is recalling specific knee implant components because defective foil pouches allowed air to enter, potentially degrading the material properties of the implants.

    Product
    Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-08-27

    Ortho Development Recalls Pivot Bipolar Cups Due to Sealing Defects

    Ortho Development is recalling Pivot Bipolar Cups because foil pouches failed to seal properly, allowing air to enter and potentially degrading the implant material.

    Product
    Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Seals

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2014-08-27

    Ortho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing

    Ortho Development is recalling various knee implant components because foil pouches failed to seal properly, allowing air to enter and potentially degrading the material properties of the implants.

    Product
    Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-08-27

    Ortho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches

    Ortho Development is recalling various knee implant components because improperly sealed foil pouches allow air to enter, increasing the risk of material degradation due to oxidation.

    Product
    Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed
    Category
    Distribution
    0 states