The Recall Desk
HighFDA (Devices)·Z-0922-2023·Announced 2023-01-18

Surgical Craniotome Attachment Ball Bearings Have Detached During Surgery

The Anspach 7.5 cm Large Rotating Craniotome Attachment ball bearings have come out during surgery or device removal. Failure to follow proper inspection intervals may result in 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 recall without reported hospitalizations or injuries. The observed failure mode (ball bearing detachment during surgery) poses a genuine risk of serious patient harm. Per the rubric, this fits the criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The FDA is recalling the 7.5 cm Large Rotating Craniotome Attachment (Ref: CRANI-L-R) manufactured by The Anspach Effort, Inc. This surgical device is used with XMax, microMax, and eMax Systems for cutting and shaping bone, including the spine and cranium.

Ball bearings in the attachment have come out, possibly during removal of the device or intra-operatively during surgery. Failure to follow the recommended inspection intervals outlined in the manufacturer's instructions for use may result in serious patient injury.

A total of 6,059 units have been distributed to the United States nationwide and to multiple countries including Australia, Canada, China, India, Japan, and several European nations. All product lots are affected (GTIN: 00845384001768).

Surgical teams using this device should carefully follow the recommended inspection intervals provided in the manufacturer's instructions for use. Healthcare providers should contact The Anspach Effort, Inc. for guidance regarding this recall.

The recalled product

Product
7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instruments
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: 00845384001768 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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