Class II — Hand Biomechanics Lab Inc
| Recalling firm | HAND BIOMECHANICS LAB, INC. |
|---|---|
| Registered facility | HAND BIOMECHANICS LAB, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A number of Agee WristJack® Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device. |
| 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 Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and exte… |
| Quantity | 65 units |
| Distribution | Nationwide Distribution |
| Initiated | 2016-09-14 |
| Classified | 2016-10-18 |
| Terminated | 2016-11-15 |
| Recall number | Z-0136-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hand Biomechanics Lab Inc (Z-0136-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75255/
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