Z-0631-2014Class II

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

Name: Z-0631-2014 Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone
Creator: The Anspach Effort, Inc.
Published: 2012-06-11
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2012-06-11 / Terminated

FDA source

The Anspach Effort, Inc. began a recall of Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone on 2012-06-11. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0631-2014
Classification: Class II
Status: Terminated
Initiated: 2012-06-11
Posted: 2014-01-06
Terminated: 2016-04-18
Recalling firm: The Anspach Effort, Inc.
Product: Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Product code: GEY Motor, Surgical Instrument, Ac-Powered
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).
FDA root cause: Unknown/Undetermined by firm
Action: none
Quantity in commerce: 4 ( BLACKMAX-N) and 1 (Foot Control)
Distribution: US Distribution: Maryland only.
Product codes and lots: Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0631-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0631-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-06
Z-0632-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-06

Product code GEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)