Reported Oct 26, 2016 · Terminated
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture…
Hand Biomechanics Lab Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hand Biomechanics Lab Inc · 77 Scripps Dr Ste 104 · Sacramento, CA · 95825-6209
Is this the product you have?
- Agee-WristJack¿ Fracture Reduction System
- Item numberCFD-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
- OrthopedicThe WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures
- Lot codes and dates
- Lot number
HBL-115-165serial numbers 47460959 and 47460980
- Lot numberHBL-116-014 - all serial numbers
- Lot numberHBL-116-040 - 15 systems shipped prior to recall
- Lot number
- Amount recalled
- 65 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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