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.
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 2/5 (Moderate).
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…
- 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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