6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended f
Summary
The FDA issued a Class II for 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ by The Anspach Effort, Inc.. Reason: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, .
Details
Source
Device Recall
External ID
Z-0919-2023
Action Date
2023-01-18
Status
Ongoing
Category
device
Product Description
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Lot/Code Info: GTIN: 00845384001744 All lots
Quantity Affected: 6059 units in total
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
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-07
Company
Palm Beach Gardens, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
The Anspach Effort, Inc. has 10 FDA actions in our database, including 9 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Anspach Effort, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Anspach Effort, Inc. have FDA actions?
The Anspach Effort, Inc. has 10 FDA actions in our database, including 9 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0919-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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