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U.S. Department of Health and Human Services

Class 2 Device Recall AgeeWristJack Fracture Reduction System

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  Class 2 Device Recall AgeeWristJack Fracture Reduction System see related information
Date Initiated by Firm September 14, 2016
Create Date October 18, 2016
Recall Status1 Terminated 3 on November 15, 2016
Recall Number Z-0136-2017
Recall Event ID 75255
510(K)Number K984442  
Product Classification Component, traction, invasive - Product Code JEC
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.
Code Information 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
Recalling Firm/
Manufacturer		 Hand Biomechanics Lab Inc
77 Scripps Dr Ste 104
Sacramento CA 95825-6209
For Additional Information Contact Dustin Dequine
916-923-5073
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JEC and Original Applicant = HAND BIOMECHANICS LAB, INC.
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