Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported January 18, 2023
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
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…
The Anspach Effort, Inc. recalled 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿… — a moderate-severity action.
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿… was recalled by The Anspach Effort, Inc. in January 18, 2023. Reason: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, po…. Check the official notice for the remedy. Verify recall #Z-0917-2023 with the FDA Devices before acting.
The recall
The Anspach Effort, Inc. issued this moderate-severity FDA Devices recall — Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, po….
- Moderate
- severity level
- 6K units
- affected scope
- Class II
- classification
- January 18, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0917-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0917-2023) was formally reported on January 18, 2023, with the manufacturer initiating the action on December 7, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. The Anspach Effort, Inc. is listed as the recalling firm, operating out of Palm Beach Gardens, FL. Federal records list the affected scope as 6059 units in total.
The documented reason for this recall is: 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 inter… Distribution data in the federal record shows the product reached: 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 Ango…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
6059 units in total
Related Recalls
6
6 from same agency
Product description
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
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0917-2023 |
| Date reported | January 18, 2023 |
| Date initiated | December 7, 2022 |
| Recalling firm | The Anspach Effort, Inc. |
| Firm location | Palm Beach Gardens, FL |
| Affected scope | 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 C… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0917-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Anspach Effort, Inc.. Units affected: 6059 units in total.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0917-2023.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0917-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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What to do next
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 18, 2023.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.