RecallRadar

FDA Device recall Z-0631-2014

Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control)

On 2014-01-15 the FDA classified a Class II recall of Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control) by The Anspach Effort, citing 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).

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0631-2014
ClassificationClass II
Statusterminated
Initiated2012-06-11
Published2014-01-15
Last updated2026-09-13 11:53 UTC
CompanyThe Anspach Effort
DistributionMD

Product

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

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).

Identifiers

code_infoSerial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0631-2014%22

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