The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0917-2023·Announced 2023-01-18

Craniotome Attachment Ball Bearings May Separate During Surgery

The FDA is recalling a surgical craniotome attachment after ball bearings can separate from the device. Failure to follow inspection protocols may result in serious patient injury during neurosurgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall affecting a surgical device where ball bearings can separate during neurosurgical use. While no injuries or illnesses have been reported, the source text states potential for 'serious patient injury.' This meets the High (3) criterion: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The Anspach Effort, Inc. is recalling the 6.5 cm Adult Craniotome with Thin Foot Plate Attachment (model CRANI-A-01) used with XMax, microMax, and eMax surgical systems. A total of 6,059 units have been distributed worldwide, including to the United States and over 40 foreign countries.

Ball bearings in the craniotome attachment can separate from the device, potentially during removal of the attachment or while in use during surgery. The manufacturer's instructions for use provide recommended inspection intervals to detect this issue. Failure to follow these inspection protocols may result in serious patient injury.

The FDA classified this as a Class II recall. Healthcare facilities and surgical centers using this equipment should perform inspections according to the manufacturer's recommended intervals. Contact the manufacturer or the FDA if you have questions or suspect an issue with your device.

The recalled product

Product
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
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: 00845384001737 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 →

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