Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
FDA device recall Z-0632-2014 · posted 2014-01-06 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- 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).
- Action taken
- none
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- GFF
- Quantity affected
- 1 B-Blue-S and 1 B-Green
- Distribution
- US Distribution: Maryland only.
- Date initiated
- 2012-06-11
- Date posted
- 2014-01-06
- Date terminated
- 2016-04-18
- Location
- Palm Beach Gardens, FL
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