Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-0136-2017

U.S. FDA — Device Enforcement · United States · 2016-09-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0136-2017
Date of alert
2016-09-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Hand Biomechanics Lab Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
47460959
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.