The Recall Desk
HighFDA (Devices)·Z-0923-2023·Announced 2023-01-18

Adult Craniotome Attachment Recalled for Ball Bearing Failure Risk

The ANSPACH CRANI-A Adult Craniotome Attachment is recalled because ball bearings can separate during use or removal, creating an intra-operative hazard. The Anspach Effort, Inc. is recalling 6,059 units distributed nationwide and internationally.

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 device is classified as FDA Class II, and the defect presents a clear risk of harm during surgical use—ball bearings loose during cranial or spinal procedures could cause serious patient injury. However, no illnesses or injuries have been reported, placing this within the 'High' severity category for risk-of-harm products without reported incidents.

Plain-English summary

The ANSPACH CRANI-A Adult Craniotome Attachment is a surgical instrument attachment used with XMax, microMax, and eMax power tool systems for bone cutting and shaping in cranial and spinal procedures. It is manufactured by The Anspach Effort, Inc.

Ball bearings in the attachment can come out of the device during use or removal. This separation can occur intra-operatively (during surgery), potentially causing serious patient injury. Failure to follow recommended inspection intervals outlined in the device's Instructions for Use may result in serious patient injury.

Approximately 6,059 units of this attachment have been distributed throughout the United States and internationally to numerous countries. Users of this device should carefully follow all inspection intervals and maintenance procedures outlined in the device's Instructions for Use.

The recalled product

Product
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Equipment
Hazard
Affected units
6,059

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: 00845384001775 All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · The Anspach Effort, Inc.

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Same hazard · bearing failure

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