Z-0728-2014 Class II Terminated
FDA device recall Z-0728-2014 was initiated by The Anspach Effort, Inc. on Dec 17, 2013 and is designated Class II. Reason for recall: Some carbide cutting burr fractured during use. The recall status is terminated (terminated May 9, 2016). Affected quantity: 28,562 total of all products in this recall.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2014
- Initiation Date
- Dec 17, 2013
- Termination Date
- May 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28,562 total of all products in this recall
Product Description
Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Reason for Recall
Some carbide cutting burr fractured during use.
Distribution Pattern
Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
Code Information
All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0728-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026