PlainRecalls
FDA Devices Moderate Class II Terminated

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

Reported: January 15, 2014 Initiated: June 11, 2012 #Z-0632-2014

Product Description

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. 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
1 B-Blue-S and 1 B-Green
Distribution
US Distribution: Maryland only.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.. Recalled by The Anspach Effort, Inc.. Units affected: 1 B-Blue-S and 1 B-Green.
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-0632-2014.