The Anspach Effort, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1907-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems

Product Classification:

Class II

Date Initiated: November 28, 2012

Date Posted: July 2, 2014

Recall Number: Z-1907-2014

Event ID: 64247

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.

Status: Terminated

Product Quantity: 130

Code Information:

Part Number: SP-3014-00; Serial Numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, 200120.

Distribution Pattern:

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. .

Voluntary or Mandated:

Voluntary: Firm initiated