Adult Craniotome Product Usage: Pneumatic system
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. Crani-A.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- The Anspach Effort, Inc.
- Reason for Recall:
- Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Adult Craniotome Product Usage: Pneumatic system
Product Codes/Lot Numbers:
All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. Crani-A.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1986-2017
Related Recalls
Pediatric Craniotome Ref:CRANI-P-G1
The Anspach Effort
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
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
The Anspach Effort
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
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