Anspach BLACKMAX-N Pneumatic Motor Recalled for CJD Exposure Risk
The Anspach Effort, Inc. is recalling four BLACKMAX-N pneumatic motors and one Autolube III foot control used in a case involving a patient with Creutzfeldt-Jacob Disease.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves exposure to Creutzfeldt-Jacob Disease (CJD), a fatal prion disease, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or high-risk pathogens.
Plain-English summary
The Anspach Effort, Inc. is recalling four Anspach BLACKMAX-N pneumatic motors and one Autolube III foot control. These devices are used for cutting and shaping bone. The recall was initiated after a hospital notified the manufacturer that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
The recalled units are distributed in Maryland. The specific serial numbers for the BLACKMAX-N motors are 1934, 3135, 50229989-3, and 31496704. The serial number for the Autolube III foot control is 80017906.
Healthcare facilities should stop using these specific devices immediately. The manufacturer is responsible for managing the recall and ensuring the devices are removed from service to prevent further exposure to the CJD pathogen.
The recalled product
- Product
- Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). 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 (4)
- Serial # 1934
- 3135
- 50229989-3
- and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
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.
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