Who else makes this device?

Name: Agee WristJack® Remanufactured
Brand: Agee WristJack® Remanufactured

Orthopedic › ProstheticComponent, Traction, Invasive

Agee WristJack® Remanufactured

Fracture reduction system, remanufactured version. Fracture reduction and external fixation for treatment of distal radius fractures.

Registry build 21.09.26

1manufacturer

1catalogue number

4510(k) clearances naming this product code

1recall

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code JEC
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Agee WristJack® Remanufactured
Listed by	Hand Biomechanics LAB, Inc., United States
FDA product code	JEC
Device type	Component, Traction, Invasive
Device class	Class 2
Regulation	21 CFR 888.3040
Establishment	Manufacturer
510(k)	K030519
Record published	2015-10-23
Record revised	2025-07-14 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2023-12-31

Catalogue Numbers

Catalogue numbers for Agee WristJack® Remanufactured
Catalogue number	Size	Status
CFD-147-RNS		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline	Medline Industries, Inc.	115
Fragment Fixation System	Orthofix SRL	77
Anjon Bremer Halo System	Anjon Holdings, LLC	68
Sheffield Ring Fixator	Orthofix SRL	68
Hoffmann	Stryker GmbH	65
Hybrid Fixator System	Orthofix SRL	30
Triax	Stryker GmbH	26
Bremer	Depuy Spine, Inc.	11
Additional Accessories FOR THE Orthofix System	Orthofix SRL	10
Component, Traction, Invasive	Synthes Gmbh	9
Distraction, Internal	KLS-Martin L.P.	9
Halo Systems	Ossur Americas	4

Showing 12 of 65. All products under Component, Traction, Invasive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K181192	2018-10-22
K072432	2008-01-09
K030519	2003-06-10
K984442	1999-02-12

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2016-09-14	Class II	Under Investigation by firm	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 (bl	65 units	2016-11-15

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.