Anspach Craniotome Recalled After Use in Creutzfeldt-Jakob Disease Case
The Anspach Effort, Inc. is recalling specific craniotome attachments used in a case involving a patient with Creutzfeldt-Jakob Disease.
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: The recall involves a high-risk pathogen (CJD) and a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
The Anspach Effort, Inc. is recalling the Anspach B-Blue-S 11.25 cm attachment and the Anspach B-Green Standard Craniotome. These devices are used for cutting and shaping bone. The recall involves one B-Blue-S attachment (Serial # 50152011-14) and one B-Green craniotome (Serial # 31447408).
The recall was initiated after a hospital informed Anspach that a Blackmax motor had been used in a surgical case where the patient was diagnosed with Creutzfeldt-Jakob Disease (CJD). The distribution of the affected units was limited to Maryland.
Healthcare facilities should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
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)
- Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green)
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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