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Recall Observatory FDA recall evidence

Device product

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

Z-0632-2014

June 11, 2012

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 67131
Status
Terminated
Classification
Class II
Quantity
1 B-Blue-S and 1 B-Green
Official record key
device-enforcement:Z-0632-2014

Official wording

Reason: Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).

Code information: Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green)

Distribution pattern: US Distribution: Maryland only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).