Anspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
The Anspach Adult Rotating Craniotome Attachment (CRANI-A-R) may have ball bearings that detach during surgical use. The FDA recommends users follow inspection intervals to prevent potential 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: FDA Class II surgical device recall describing risk of serious patient injury from intraoperative ball bearing detachment. No injuries or deaths have been reported, placing this within the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
The FDA is recalling the 6.5 cm Adult Rotating Craniotome Attachment, model CRANI-A-R, manufactured by The Anspach Effort, Inc. This attachment is used with XMax, microMax, and eMax surgical systems for cutting and shaping bone during neurosurgery procedures.
Ball bearings in the attachment may come loose and separate from the device, possibly during removal of the attachment from the surgical handpiece. If this occurs during surgery, loose ball bearings could pose a serious risk to the patient.
Approximately 6,059 units have been distributed in the United States and internationally. The manufacturer recommends that surgical staff and healthcare facilities follow the inspection intervals provided in the device instructions for use to identify potential issues before use in procedures.
The recalled product
- Product
- 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
- Manufacturer
- The Anspach Effort, Inc.
- 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: 00845384001744 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.
See all →- HighAdult Craniotome Ball Bearing Separation Risk During Neurosurgery
FDA (Devices) · 2023-01-18
- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighPediatric Craniotome Recalled for Ball Bearing Detachment Risk
FDA (Devices) · 2023-01-18
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