The Recall Desk
HighFDA (Devices)·Z-0924-2023·Announced 2023-01-18

Pediatric Craniotome Recalled for Ball Bearing Detachment Risk

The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing 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 a Class II FDA recall of a medical device with potential for serious patient injury during surgical use. No illnesses or injuries have been reported in the source text. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' which scores as High.

Plain-English summary

The Anspach Effort, Inc. is recalling 6,059 units of the Pediatric Craniotome (Model CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during removal or during surgical use.

When ball bearings detach during use, they can cause serious patient injury. The FDA classified this as a Class II recall. According to the manufacturer, failure to follow the recommended inspection intervals provided in the Instructions for Use may result in serious patient harm.

These devices were distributed nationwide in the United States and internationally to numerous countries including Australia, Canada, China, India, Japan, and the United Kingdom, among others. All production lots are affected by this recall.

For questions regarding this recall, healthcare facilities should contact The Anspach Effort, Inc. for additional information and instructions.

The recalled product

Product
Pediatric Craniotome Ref:CRANI-P-G1
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: 00845384016403 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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