Hand Biomechanics Lab Recalls Agee WristJack Fracture Reduction Systems
Hand Biomechanics Lab Inc is recalling 65 Agee WristJack Fracture Reduction Systems because a molded beam is slightly larger than optimal, which may make surgical adjustments difficult.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves difficulty in device adjustment rather than a direct, reported injury or high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Hand Biomechanics Lab Inc is recalling 65 units of the Agee WristJack Fracture Reduction System, item number CFD-147. This single-use medical device is used for the treatment of distal radius fractures in trauma-related surgery. The affected units were distributed nationwide.
The recall was initiated because a number of the systems were manufactured with a molded beam that is slightly larger than optimal. This design deviation may result in the surgeon experiencing difficulty fine-tuning the length and radial/ulnar alignment adjustments on the device.
The recall covers specific lots and serial numbers: Lot number HBL-115-165 (serial numbers 47460959 and 47460980), Lot number HBL-116-014 (all serial numbers), and Lot number HBL-116-040 (15 systems shipped prior to recall). Healthcare providers and facilities should stop using these devices and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack
- Manufacturer
- Hand Biomechanics Lab Inc
- Category
- Medical Device — Orthopedic
- Hazard
- Affected units
- 65
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)
- Lot number: HBL-115-165
- serial numbers 47460959 and 47460980
- Lot number: HBL-116-014 - all serial numbers
- Lot number : HBL-116-040 - 15 systems shipped prior to recall
Distribution
Distributed nationwide across the United States.
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