Device product
ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
Z-2296-2015
Product summary
- Event
- Event 71212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 103 tools.
- Official record key
device-enforcement:Z-2296-2015
Official wording
Reason: 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.
Code information: REF M-5BA-A-G1 ; ALL lot numbers
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.
Derived failure modes
-
Unknown
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.