Z-1668-2016 Class II Terminated
FDA device recall Z-1668-2016 was initiated by The Anspach Effort, Inc. on Mar 28, 2016 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated Dec 14, 2016). Affected quantity: 27 devices.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2016
- Initiation Date
- Mar 28, 2016
- Termination Date
- Dec 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 devices
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Distribution in the states of KY and TX.
Code Information
Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1668-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026