Craniotome Attachment Ball Bearings May Detach During Surgery
The Anspach 6.5 cm Adult Rotating Craniotome Attachment may have ball bearings that detach during surgical use or removal. The manufacturer recommends following inspection intervals to prevent 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 an FDA Class II medical device with potential for serious patient injury if manufacturer-recommended inspection intervals are not followed. No actual illnesses or injuries have been reported in the source text. As a risk-of-harm product without reported harm, this meets the High (3) severity threshold.
Plain-English summary
The Anspach 6.5 cm Adult Rotating Craniotome Attachment (model CRANI-A) is used with XMax, microMax, and eMax surgical systems for cutting and shaping bone, including spinal and cranial procedures.
Ball bearings within the attachment may detach, potentially during removal of the attachment or during surgical use. Such detachment could result in serious patient injury. The manufacturer has identified this hazard and recommends specific inspection intervals outlined in the product's Instructions for Use.
Approximately 6,059 units have been distributed to the United States and to countries worldwide. Healthcare facilities and surgical teams using this attachment should follow the manufacturer's recommended inspection intervals as provided in the product's Instructions for Use to ensure safe operation.
The recalled product
- Product
- 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- bearing-detachment
- intra-operative-incident
- equipment-malfunction
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: 00845384001720 All lots
Distribution
Distributed nationwide across the United States.
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