Facility

HAND BIOMECHANICS LAB, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	2919128
Establishment type	Manufacture Medical Device
Location	77 Scripps Dr Ste 104 SACRAMENTO, CA, US 95825
Registration status	Active · expires 2026
Parent company	HAND BIOMECHANICS LAB, INC. (owner-operator 2919128)
Brand names	AGEE-WRISTJACK SYSTEM-STERILE; WristJack®; Agee WristJack® External Fixation System; Agee WristJack® External Fixation System, Sterile; Agee-WristJack® Fracture Reduction System, Sterile; Agee WristJack®

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Component, Traction, Invasive
Product code JEC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

Class IITerminated2016-09-14
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.

FDA inspections (2)

VAI2018-04-04
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2017-07-05
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2017-11-16
Warning Letter (opens in a new tab) · Sacramento California

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by HAND BIOMECHANICS LAB, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HAND BIOMECHANICS LAB, INC. (FEI 2919128) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2919128-hand-biomechanics-lab-inc/

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