The Anspach Effort, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0922-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium

Product Classification:

Class II

Date Initiated: December 7, 2022

Date Posted: January 18, 2023

Recall Number: Z-0922-2023

Event ID: 91231

Reason for Recall:

Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury

Status: Ongoing

Product Quantity: 6059 units in total

Code Information:

GTIN: 00845384001768 All lots

Distribution Pattern:

US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada

Voluntary or Mandated:

Voluntary: Firm initiated