CLASS II ONGOING Device recall · Reported 18 Jan 2023 · FDA Enforcement Report

Adult Craniotome, Thin Foot Plate Attachment recalled

The Anspach Effort is recalling Adult Craniotome, Thin Foot Plate Attachment, distributed nationwide in the US. The recall was initiated on 7 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 00845384001737 All lots

Quantity recalled6059 units in total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0917-2023
FDA event ID: 91231
Recalling firm: The Anspach Effort, Palm Beach Gardens, FL
Classification: Class II
Status: Ongoing
Recall initiated: 7 Dec 2022
FDA classified: 6 Jan 2023
Reported: 18 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Spinal Implants

Timeline

7 Dec 2022	Recall initiated by company
6 Jan 2023	Classified by FDA	+30 days
18 Jan 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel

Where it was distributed

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

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN: 00845384001737 All lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 91231

This product is part of a recall event; the main page for the event is Pediatric Craniotome recalled by The Anspach Effort.

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023	CLASS II	Pediatric Craniotome recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Adult Craniotome, Large recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Large Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Pediatric Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Large Craniotome Attachment Use with XMax¿, microMax recalled	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023	CLASS II	Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide

More recalls from The Anspach Effort

All 260

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Device	CLASS II	Adult Craniotome recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Adult Rotating Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Large Craniotome Attachment Use with XMax¿, microMax recalled	The Anspach Effort	Processing Deviation	Nationwide
18 Jan 2023Device	CLASS II	Pediatric Craniotome Attachment recalled by The Anspach Effort	The Anspach Effort	Processing Deviation	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide