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FDA Medical Device Recalls (openFDA)

The Anspach Effort, Inc.: Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

Recall number
Z-0632-2014
Recalling firm
The Anspach Effort, Inc.
Product
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
Status
Terminated
Initiated
2012-06-11
Posted
2014-01-06
Terminated
2016-04-18
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
1 B-Blue-S and 1 B-Green
Distribution
US Distribution: Maryland only.
Lot, serial or model codes
Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green)
510(k) numbers
not on file
PMA numbers
not on file
Product code
GFF
Firm FEI
1045834
Firm city
Palm Beach Gardens
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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