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HAND BIOMECHANICS LAB, INC.

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Agee TurnKey FCS®	FCS-400	FDA UDI	Class II	Unknown
Agee WristJack® Remanufactured	CFD-147-RNS	FDA UDI	Class II	Unknown
Agee Digit Widget®	DWD-232	FDA UDI	Class II	Active
PIP Fix	PFX-426	FDA UDI	Class II	Active
Agee WristJack®	CFD-147	FDA UDI	Class II	Active
Disposable Blade Assembly	CTR-455	FDA UDI	Class II	Active
Agee-Wristjack Pre-Drill Kit	K942906	FDA 510(k)	Class I	Active
HBL Blade Assembly	K222490	FDA 510(k)	Class II	Active
Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models Cfd-347, Cfd-347-Ns	K033112	FDA 510(k)	Class II	Active
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly	K252020	FDA 510(k)	Class II	Active
PIP Fix	K181192	FDA 510(k)	Class II	Active
Wristjack System (remanufactured), Sterile And Non-Sterile, Models Cfd-147-Rs, Cfd-247-Rns	K030519	FDA 510(k)	Class II	Active
F3 Fractured Finger Fixator, Sterile (model: Fcs 400) And Non Sterile	K072432	FDA 510(k)	Class II	Active
Digit Widget	K992970	FDA 510(k)	Class II	Active
Agee-Wristjack Fracture Reaction System (sterile Version), Model Cfd-147	K984442	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 14, 2016	Z-0136-2017	—	terminated	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.