FDA-Device2014-01-15Class II
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. 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
1 B-Blue-S and 1 B-Green
Manufactured in
4500 Riverside Drive, Palm Beach Gardens, FL, United States
Products
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0632-2014Don't want to check this manually?
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