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Class 3 Device Recall DRLock Volar Plate Screw System, model DVR900 |
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Date Initiated by Firm |
August 03, 2006 |
Date Posted |
January 19, 2007 |
Recall Status1 |
Terminated 3 on September 10, 2012 |
Recall Number |
Z-0349-2007 |
Recall Event ID |
36843 |
510(K)Number |
K053182
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Product Classification |
Plate Screw System distal radius of hand - Product Code HRS
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Product |
DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires. |
Code Information |
Tray kit (case) set number: ''BAA'', ''BAB'', ''BAC'', ''BAD'', ''BAE'', ''BAF'', ''BAH'', and ''BAJ''. (The distal locking-screws contained in the kit are identified with lot numbers S104 and S200) |
Recalling Firm/ Manufacturer |
OrthoHelix Surgical Designs Inc 1815 W Market St Ste 205 Akron OH 44313-7018
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For Additional Information Contact |
Rick L. Kovach 330-869-9562
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Manufacturer Reason for Recall |
The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm contacted all consignees by phone on or about 8/3/06. |
Quantity in Commerce |
180 |
Distribution |
The product was distributed to 5 consignees located in the U.S.: Archway Medical, Columbia, SC; Gulf Coast Surgical, Stafford, TX; Vaugham Medical, Wheat Ridge, CO; Belemy Medical, Cleveland, OH; and Crystal Clinic, Akron, OH. |
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 = HRS and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.
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