The Recall Desk

FDA (Devices) recall action 71575

Zimmer Surgical Inc recalled 2 products on 2015-08-12

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
2015-08-12
Critical
0
Units
391

Why these products were recalled

The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.

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

  • ModerateFDA (Devices)··2015-08-12

    Zimmer Surgical Recalls Tourniquet Cuffs with Missing Instructions

    Zimmer Surgical Inc. is recalling 330 units of 30-inch tourniquet cuffs because the instructions for use were missing usage instructions and warnings.

    Product
    30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder…
    Category
    Distribution
    45 states
  • LowFDA (Devices)··2015-08-12

    Zimmer Surgical Recalls Tourniquet Cuffs Due to Missing Instructions

    Zimmer Surgical Inc. is recalling 61 units of 18-inch disposable tourniquet cuffs because the folded instructions for use pamphlet was missing usage instructions and warnings.

    Product
    18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder…
    Category
    Distribution
    45 states