The Recall Desk

FDA (Devices) recall action 65863

The Anspach Effort, Inc. recalled 3 products on 2013-11-20

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
2013-11-20
Critical
0
Units
6,060

Why these products were recalled

Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

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.

1–3 of 3

  • ModerateFDA (Devices)··2013-11-20

    Anspach Effort Recalls Cutting Bur Chart Due to Labeling Error

    Anspach Effort, Inc. is correcting labeling on its Cutting Bur Chart and related manuals because a claim about cutting biometals was not part of the device's intended use.

    Product
    Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2013-11-20

    Anspach Effort Pneumatic Systems Operating Manual Labeling Correction

    Anspach Effort is correcting labeling on Pneumatic Systems Operating Manuals to remove unverified claims about cutting biometals, bioplastics, and cement.

    Product
    Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-20

    Anspach Effort Recalls Pneumatic Systems Operating Manual and Product Catalog

    Anspach Effort, Inc. is correcting labeling on its Pneumatic Systems Operating Manual and Product Catalog because a claim regarding the device's capability to dissect biometals, bioplastics, and cement was found to be inaccurate.

    Product
    Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting an
    Category
    Distribution
    0 states