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Terminated

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

FDA Recall Z-0631-2014 · Posted 2014-01-06

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeGEY
Date Initiated2012-06-11
Date Terminated2016-04-18
Product Quantity4 ( BLACKMAX-N) and 1 (Foot Control)

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).

Firm Action

none

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Distribution: Maryland only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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