Z-1377-2013 Class II Terminated
FDA device recall Z-1377-2013 was initiated by The Anspach Effort, Inc. on Mar 4, 2011 and is designated Class II. Reason for recall: Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. The recall status is terminated (terminated Dec 17, 2013). Affected quantity: 1,827 burrs.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 5, 2013
- Initiation Date
- Mar 4, 2011
- Termination Date
- Dec 17, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,827 burrs
Product Description
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Reason for Recall
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
Code Information
Lots numbers: D433040800, D403040236, D383039472.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1377-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026