Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
FDA device recall Z-0631-2014 · 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
- GEY
- Quantity affected
- 4 ( BLACKMAX-N) and 1 (Foot Control)
- 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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