Recall Z-0136-2017 ยท JEC Component, Traction, Invasive
Hand Biomechanics Lab Inc
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
| Date | Sep 14, 2016 |
| Status | Terminated |
| Reason | 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 | 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 | 65 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984442 | AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 Hand Biomechanics Lab, Inc., Feb 12, 1999 |