Z-0917-2023Class II

6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref...

Name: Z-0917-2023 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref...
Creator: The Anspach Effort, Inc.
Published: 2022-12-07
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2022-12-07 / Open, Classified / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of 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... on 2022-12-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0917-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-07
Posted: 2023-01-07
Recalling firm: The Anspach Effort, Inc.
Product: 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
Product code: HBC Motor, Drill, Electric
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
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: DePuy Synthes initiated "URGENT: MEDICAL DEVICE CORRECTION (Notification)" via UPS on 12/07/22. Letter states reason for recall, health risk an action to be taken. The customers were instructed to do the following: Review your inventory and make a plan to follow the suggested manufacturer inspection interval of 12 months associated with your product, as specified in the IFU. " Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). " If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. " Once this notification is received, please complete, sign, and return the attached Business Response Form (page 3 of this letter) via Fax: 877-496-5042 or Scan/email: [email protected] within 3 business days of receipt of this notification. Contact your Product Support Team through email at [email protected] or via phone at 1-800.327.6887, option #2 for additional support as needed.
Quantity in commerce: 6059 units in total
Distribution: 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
Product codes and lots: GTIN: 00845384001737 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0917-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0916-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0917-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0918-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0919-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0920-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0921-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0922-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0923-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06
Z-0924-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-06

Product code HBC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)