The Recall Desk
HighFDA (Devices)·Z-0920-2023·Announced 2023-01-18

Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery

Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.

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 with documented risk of serious patient injury from ball bearings loosening during cranial surgery. However, no injuries have been reported in the source text, meeting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

The FDA has issued a Class II recall of The Anspach Effort's 7.5 cm Large Craniotome Attachment (CRANI-L) for use with XMax, microMax, and eMax Systems. A total of 6,059 units have been distributed. This device is used in surgical procedures to cut and shape bone, including the cranium and spine.

Ball bearings within the attachment may come loose and come out during removal of the attachment or while the device is in use during surgery. The manufacturer has recommended inspection intervals in the Instructions for Use (IFU) to prevent this problem. Failure to follow these intervals may result in serious patient injury.

The affected attachment has been distributed to hospitals and surgical centers nationwide in the United States and internationally, including Australia, Canada, China, France, Germany, India, Japan, Mexico, and many other countries.

Healthcare facilities using this device should ensure that the manufacturer's recommended inspection intervals, as provided in the Instructions for Use, are strictly followed.

The recalled product

Product
7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Equipment
Hazard
  • bearing-failure
  • loose-parts

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: 00845384001751 All lots

Distribution

Distributed nationwide across the United States.

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