Z-0136-2017Class II

Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a...

Name: Z-0136-2017 Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a...
Creator: Hand Biomechanics Lab Inc
Published: 2016-09-14
License: https://open.fda.gov/license/

Hand Biomechanics Lab Inc / initiated 2016-09-14 / Terminated / root cause: manufacturing process

FDA source

Hand Biomechanics Lab Inc began a recall of Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system... on 2016-09-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0136-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-14
Posted: 2016-10-18
Terminated: 2016-11-15
Recalling firm: Hand Biomechanics Lab Inc
Product: 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 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. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
Product code: JEC Component, Traction, Invasive
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Hand Biomechanics Lab, Inc. sent a Voluntary Medical Device Recall letter to all affected customers beginning on September 14, 2016 and sent by phone/fax numbers - or e-mail. Letters request return of devices which have not yet been used. Customers with questions were instructed to contact Customer Service at (800) 522-5778. For questions regarding this recall call 916-923-5073.
Quantity in commerce: 65 units
Distribution: Nationwide Distribution
Product codes and lots: Lot number: HBL-115-165, serial numbers 47460959 and 47460980; Lot number: HBL-116-014 - all serial numbers; Lot number : HBL-116-040 - 15 systems shipped prior to recall

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0136-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0136-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-26	2016-10-18

Product code JEC

K984442Class IIAgee-Wristjack Fracture Reaction System (Sterile Version), Model Cfd-147Hand Biomechanics Lab, Inc. / cleared 1999-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)