The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0921-2023·Announced 2023-01-18

Adult Craniotome Ball Bearing Separation Risk During Neurosurgery

The Anspach Adult Craniotome Large attachment ball bearings may separate during surgical removal or intra-operatively, potentially causing serious patient injury.

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 an FDA Class II recall of a surgical device with an identified risk of component separation during neurosurgery. While the hazard is clearly stated and poses risk of serious patient injury, no injuries or hospitalizations have been reported in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

The Anspach Adult Craniotome, Large (Reference CRANI-L-G1) is a surgical instrument used for cutting and shaping bone during neurosurgical procedures, including craniotomy and spinal operations. Approximately 6,059 units have been distributed worldwide, including throughout the United States and to numerous countries internationally. All lot numbers are affected by this recall.

Ball bearings in the CRANI-A attachment may separate from the attachment during removal or intra-operatively. If the bearings separate during surgery, they pose a serious risk to patient safety. The FDA has classified this as a Class II recall.

Healthcare facilities and surgeons should strictly follow the inspection intervals provided in the device's instructions for use before each procedure. Any craniotome exhibiting signs of bearing damage or separation should not be used. Facilities should contact The Anspach Effort, Inc. for further guidance or information regarding this recall.

The recalled product

Product
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Neurosurgical Instrument
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: 00845384016427 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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