Home / Recalls / The Anspach Effort, Inc. / Z-0919-2023

Z-0919-2023 Class II Ongoing

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-0919-2023 was initiated by The Anspach Effort, Inc. on December 7, 2022 and is designated Class II. 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 recommend… The recall status is ongoing. Affected quantity: 6059 units in total.

Recall Details

Product Type: Devices
Report Date: January 18, 2023
Initiation Date: December 7, 2022
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6059 units in total

Product Description

6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium

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

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

Code Information

GTIN: 00845384001744 All lots

Other recalls by The Anspach Effort, Inc.

Z-0924-2023 Class II — Pediatric Craniotome Ref:CRANI-P-G1 (December 7, 2022)
Z-0922-2023 Class II — 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ (December 7, 2022)
Z-0921-2023 Class II — Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bo (December 7, 2022)
Z-0917-2023 Class II — 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, (December 7, 2022)
Z-0916-2023 Class II — 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ (December 7, 2022)
Z-0920-2023 Class II — 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. (December 7, 2022)
Z-0918-2023 Class II — Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone incl (December 7, 2022)
Z-0923-2023 Class II — 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Syst (December 7, 2022)
Z-0398-2018 Class II — OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachm (September 29, 2017)
Z-1950-2017 Class II — eMax2 Motor Assembly Product Usage: Electric system (October 6, 2016)