PlainRecalls
FDA Devices Moderate Class II Terminated

Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

Reported: January 15, 2014 Initiated: June 11, 2012 #Z-0631-2014

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).

Details

Recalling Firm
The Anspach Effort, Inc.
Units Affected
4 ( BLACKMAX-N) and 1 (Foot Control)
Distribution
US Distribution: Maryland only.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.. Recalled by The Anspach Effort, Inc.. Units affected: 4 ( BLACKMAX-N) and 1 (Foot Control).
Why was this product recalled?
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).
Which agency issued this recall?
This recall was issued by the FDA Devices on January 15, 2014. Severity: Moderate. Recall number: Z-0631-2014.