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.
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: 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
Same manufacturer · The Anspach Effort, Inc.
See all →- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Separate During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighAnspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
Same hazard · infection
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19