The Recall Desk

FDA (Devices) recall action 64973

The Anspach Effort, Inc. recalled 3 products on 2013-07-10

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2013-07-10
Critical
0
Units
183

Why these products were recalled

The RPM of the Motor Handpiece may be less than 80,000 RPM.

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

1–3 of 3

  • ModerateFDA (Devices)··2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus Consoles because the motor handpiece may operate at lower speeds than specified.

    Product
    ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. The RPM of the Motor Handpiece may be less than…
    Category
    Distribution
    12 states
  • ModerateFDA (Devices)··2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low Motor RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may operate at lower than expected speeds in free-running conditions.

    Product
    ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be…
    Category
    Distribution
    12 states
  • ModerateFDA (Devices)··2013-07-10

    Anspach Effort eMax 2 Plus Console Recalled for Low RPM

    The Anspach Effort, Inc. is recalling eMax 2 Plus dental consoles because the motor handpiece may run at lower than expected speeds in free-running mode.

    Product
    ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece…
    Category
    Distribution
    12 states