The Recall Desk

FDA (Devices) recall action 83671

Howmedica Osteonics Corp. recalled 4 products on 2019-10-09

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2019-10-09
Critical
0
Units
650

Why these products were recalled

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

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

1–4 of 4

  • HighFDA (Devices)··2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 159 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 153 units of Triathlon Femoral Distal Augments because a device overhang issue causes them to protrude beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See att
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 167 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to
    Category
    Distribution
    49 states