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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JEC
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