The Recall Desk

FDA (Devices) recall action 73738

The Anspach Effort, Inc. recalled 2 products on 2016-05-25

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
2016-05-25
Critical
0
Units
54

Why these products were recalled

Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.

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)··2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Distribution
    2 states
  • ModerateFDA (Devices)··2016-05-25

    Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating

    The Anspach Effort, Inc. is recalling 27 Otologic Curved Micro Diamond Ball Burrs because they may be missing the diamond coating or be the incorrect size.

    Product
    ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
    Category
    Distribution
    2 states