The Recall Desk

Manufacturer

Ortho Development Corporation

8 recalls in our database name Ortho Development Corporation as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
2
Most recent
2020-05-13

Of the 8 recalls from Ortho Development Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (25%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • HighFDA (Devices)·Z-1903-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Due to Manufacturing Defect

    Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1904-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Components Due to Manufacturing Defect

    Ortho Development Corporation is recalling 29 tibial tray components due to a manufacturing defect that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2256-2014·2014-08-27

    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
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2254-2014·2014-08-27

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2014·2014-08-27

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2257-2014·2014-08-27

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2255-2014·2014-08-27

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1610-2014·2014-05-21

    Ortho Development Recalls PS-C Femoral Knee Implant Components

    Ortho Development Corporation is recalling five PS-C Femoral Nonporous Rt Sz 6 knee implant components because pegged versions were found in boxes labeled for the pegless version.

    Product
    PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide