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Recall Observatory FDA recall evidence

Device product

ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.

Z-2305-2015

April 13, 2015

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 71212
Status
Terminated
Classification
Class II
Quantity
70 tools.
Official record key
device-enforcement:Z-2305-2015

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 S-3SDC-22-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

    reason.no_named_rule · v1.0.0

    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.