Adult Craniotome Bearings May Detach During Surgical Use
Ball bearings in the Anspach Adult Craniotome attachment may detach during removal or during surgery. Failure to follow recommended inspection intervals increases the risk of serious patient injury.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall with a demonstrated mechanical failure in a surgical instrument. No illnesses or injuries have been reported in the source, but the risk of serious patient harm during critical surgical procedures is explicitly stated. This meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
The FDA is recalling the Adult Craniotome attachment (Ref: CRANI-A-G1) made by The Anspach Effort, Inc. Ball bearings in this surgical attachment may come loose and detach during removal of the attachment or during intra-operative use. The detachment of ball bearings may result in serious patient injury, particularly if recommended inspection intervals are not followed.
The recall involves 6,059 units distributed nationwide throughout the United States and internationally to countries including Australia, Canada, the United Kingdom, and many others. All lot numbers of the affected product are included in this recall.
The manufacturer's instructions for use contain recommended inspection intervals. Failure to follow these inspection intervals is associated with increased risk of serious patient injury from bearing detachment. Medical facilities using this device should refer to the manufacturer's instructions for use for guidance on proper inspection and maintenance procedures.
The recalled product
- Product
- Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- bearing-detachment
- equipment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN: 00845384016410 All lots
Distribution
Distributed nationwide across the United States.
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