Recall Z-0631-2014 ยท GEY Motor, Surgical Instrument, Ac-Powered
The Anspach Effort, Inc.
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
| Date | Jan 6, 2014 (initiated Jun 11, 2012) |
| Status | Terminated |
| 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). |
| Root cause | Unknown/Undetermined by firm |
| Action | none |
| Quantity | 4 ( BLACKMAX-N) and 1 (Foot Control) |
| Distribution | US Distribution: Maryland only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.