FDA-Device2014-01-15Class II
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
The Anspach Effort, Inc.
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).
Sold states
US Distribution: Maryland only.
Affected count
4 ( BLACKMAX-N) and 1 (Foot Control)
Manufactured in
4500 Riverside Drive, Palm Beach Gardens, FL, United States
Products
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0631-2014Don't want to check this manually?
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