Recall archive / FDA device enforcement
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting... — FDA record Z-0923-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
- Reason
- 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
- Classification
- Class II
- Recalling firm
- The Anspach Effort, Inc.
- Quantity
- 6059 units in total
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0923-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 00845384001775 All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 18, 2023
- Recall initiation date
- Dec 7, 2022
- Center classification date
- Jan 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.