Z-0631-2014 Class II Terminated
FDA device recall Z-0631-2014 was initiated by The Anspach Effort, Inc. on Jun 11, 2012 and is designated Class II. 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). The recall status is terminated (terminated Apr 18, 2016). Affected quantity: 4 ( BLACKMAX-N) and 1 (Foot Control).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 15, 2014
- Initiation Date
- Jun 11, 2012
- Termination Date
- Apr 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 ( BLACKMAX-N) and 1 (Foot Control)
Product Description
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
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).
Distribution Pattern
US Distribution: Maryland only.
Code Information
Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0631-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026