The Recall Desk

FDA (Devices) recall action 78759

Zimmer Surgical Inc recalled 2 products on 2018-02-21

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
2018-02-21
Critical
0
Units
16,462

Why these products were recalled

Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

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)··2018-02-21

    Zimmer Surgical Recalls A.T.S. 4000TS Tourniquet Systems for Labeling Updates

    Zimmer Surgical Inc is recalling 8,231 A.T.S. 4000TS Tourniquet Systems to update on-device labels and operator manuals, and to reduce the required separation distance from RF communication equipment.

    Product
    A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. .
    Category
    Distribution
    52 states
  • ModerateFDA (Devices)··2018-02-21

    Zimmer Surgical Recalls A.T.S. 2200TS Tourniquet Systems for Labeling Updates

    Zimmer Surgical is recalling 8,231 A.T.S. 2200TS Tourniquet Systems to update on-device labels and operator manuals regarding RF communication equipment separation distances.

    Product
    A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, Inc. Dover, OH 44622 Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
    Category
    Distribution
    52 states