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Recall Observatory FDA recall evidence

Device product

ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

Z-1574-2014

January 08, 2014

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 68109
Status
Terminated
Classification
Class II
Quantity
30 cutting burs affected
Official record key
device-enforcement:Z-1574-2014

Official wording

Reason: Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

Code information: Lot/Set/Serial: G323081803.

Distribution pattern: Nationwide Distribution including FL, TX, NC, IL, CO, and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.