ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.
- 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:
- The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
Product Codes/Lot Numbers:
Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.
Distribution:
Distributed in: AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1897-2014
Related Recalls
Pediatric Craniotome Ref:CRANI-P-G1
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Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
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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