FDAFDA · Food and drugs·Recall number Z-0631-2014
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Published January 15, 2014 · Recall initiated: June 11, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- US Distribution: Maryland only.
- Lot
- Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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