The Anspach Effort, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1906-2014)

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***1.85mm x 16 mm Fluted Router 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-1906-2014

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: 113

Code Information:

Part Number: SP-3013-00; SP-3013-01; SP-3013-02; SP-3013-03. Serial Numbers: 200042, 200044, 200014, 200056, 200064, 200055, 200044, 200038, 200013, 310009, 310007, 20043, 200145, 200144.

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