Z-2307-2015 Class II Terminated
FDA device recall Z-2307-2015 was initiated by The Anspach Effort, Inc. on Apr 13, 2015 and is designated Class II. Reason for recall: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each… The recall status is terminated (terminated Aug 25, 2016). Affected quantity: 99 tools.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 5, 2015
- Initiation Date
- Apr 13, 2015
- Termination Date
- Aug 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 tools.
Product Description
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bone including spine and cranium.
Reason for Recall
G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
Distribution Pattern
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Code Information
REF S-4DC-22-G1 ; ALLlot numbers.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2307-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026