The Anspach Effort, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1989-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Large Craniotome Product Usage: Pneumatic system

Product Classification:

Class II

Date Initiated: October 6, 2016

Date Posted: May 10, 2017

Recall Number: Z-1989-2017

Event ID: 76059

Reason for Recall:

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Status: Terminated

Product Quantity: 930

Code Information:

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CRANI-L.

Distribution Pattern:

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

Voluntary or Mandated:

Voluntary: Firm initiated