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Recall Observatory FDA recall evidence

Device product

G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.

Z-2839-2016

August 26, 2016

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 75121
Status
Terminated
Classification
Class II
Quantity
63
Official record key
device-enforcement:Z-2839-2016

Official wording

Reason: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

Code information: Material M-3SB-2-G1 Batch J316017640

Distribution pattern: AZ, DC, CA, MD, MI, and OR Switzerland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.