Recall Z-0136-2017— Hand Biomechanics Lab Inc

Name: FDA recall Z-0136-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-14

Class II · Terminated

Class II FDA medical device recall by Hand Biomechanics Lab Inc, initiated 2016-09-14, terminated 2016-11-15. It names one FDA 510(k) clearance: K984442. 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.. 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..

Recalling firm: Hand Biomechanics Lab Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-14
Terminated: 2016-11-15
Firm location: Sacramento, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K984442 — AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147Hand Biomechanics Lab, Inc.·cleared 1999-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.