Z-1907-2014Class II

ANSPACHREF SP-3014-004mm Fluted Ball for MRIRx Only This device is intended to be used with...

Name: Z-1907-2014 ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with...
Creator: The Anspach Effort, Inc.
Published: 2012-11-28
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2012-11-28 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems on 2012-11-28. FDA classified it as Class II and gives the reason as "The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1907-2014
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Posted: 2014-06-25
Terminated: 2014-08-07
Recalling firm: The Anspach Effort, Inc.
Product: ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.
Quantity in commerce: 130
Distribution: Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
Product codes and lots: Part Number: SP-3014-00; Serial Numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, 200120.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1907-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1875-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1876-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1877-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1878-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1879-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1880-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1881-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1882-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1883-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1884-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1885-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1886-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1887-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1888-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1889-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1890-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1891-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1892-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1893-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1894-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1895-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1896-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1897-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1898-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1899-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1900-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1901-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1902-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1903-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1904-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1905-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1906-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1907-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1908-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1909-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1910-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1911-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1912-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1913-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1914-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1915-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1916-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1917-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1918-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25
Z-1919-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-02	2014-06-25

Product code HBB

K040186Class IIAnspach MRI Safe Surgical Drill SystemThe Anspach Effort, Inc. / cleared 2004-04-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)