The Recall Desk

FDA (Devices) recall action 91489

Biomet, Inc. recalled 2 products on 2023-02-08

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
2023-02-08
Critical
0
Units
248

Why these products were recalled

Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

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)··2023-02-08

    Biomet Vanguard Knee Implant Components Recalled for Incorrect Labeling

    Biomet, Inc. is recalling specific Vanguard Knee System prosthetic components that are incorrectly labeled with wrong sizes and sides. This labeling error could result in incorrect implant placement during knee replacement surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left;
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2023-02-08

    Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side

    Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Num
    Category
    Distribution
    6 states